Effect of antithrombotic agents on the patency of PTFE-Covered stents in the inferior vena cava: An experimental study

Purpose: To evaluate the efficacy of antithrombotic agents in the prevention of stenosis of polytetrafluoroethylene (PTFE)-covered stents in the venous system. Methods: Spiral Z stents covered with PTFE (PTFE-covered stents) were placed in the inferior vena cava (IVC) of 34 dogs. Nineteen dogs, used as a control group, were sacrificed at 2, 4, and 12 weeks. Fifteen dogs, previously given antithrombotic agents [cilostazol (n= 5), warfarin potassium (n= 5), cilostazol plus warfarin potassium (n= 5)] were sacrificed at 4 weeks, and then examined angiographically and histopathologically. The effect of the antithrombotic agents was compared between groups. Results: The patency rate of the antithrombotic agent group was 93% (14/15), which was higher than the control group rate of 63% (12/19). The mean stenosis rate of the patent stent at both ends and at the midportion was lower at 4 weeks in the antithrombotic agent group than in the control group. In particular, the mean stenosis rate in the cilostazol plus warfarin potassium group was significantly lower than the control group (Tukey's test, p < 0.05). The mean neointimal thickness of the patent stent at both ends and at the midportion was thinner at 4 weeks in the antithrombotic agent group than in the control group. In particular, the thickness of the neointima in the cilostazol plus warfarin potassium group was significantly decreased when compared with the control group (Tukey's test p < 0.05). At 4 weeks, endothelialization in the antithrombotic agent group tended to be almost identical to that in the control group. Conclusion: The present study suggests that administration of an antithrombotic agent is an effective way of preventing the stenosis induced by a neointimal thickening of PTFE-covered stents in the venous system.     

Management of failing prosthetic bypass grafts with metallic stent placement

Purpose: To evaluate the role of metallic stents in treating stenoses involving prosthetic arterial bypass grafts. Methods: Patients undergoing stent placement within a failing prosthetic bypass graft, during a 41-month period, were reviewed for treatment outcome and complications. The indications for stent placement in 15 patients included severe claudication (n= 3), rest pain (n= 9), and minor or major tissue loss (n= 3). Lesions were at the proximal anastomosis (n= 6), the distal anastomosis (n= 3), or within the graft (n= 6). Results: Treatment with metallic stents was successful in all patients. There was one acute stent thrombosis, successfully treated with thrombolytic therapy. Follow-up data are available for a mean duration of 12.3 months. The mean duration of primary patency was 9.4 months with 6- and 12-month primary patency rates of 51.9% and 37.0%, respectively. The mean duration of secondary patency was 12.1 months with 6- and 12-month secondary patency rates of 80.0% and 72.7%, respectively. Two patients with discontinuous runoff and preexisting gangrene required a below-knee amputation. Six patients were revised surgically after stent placement (at a mean of 10.8 months). Three late deaths occurred during follow-up. Conclusion: Given the mortality risks of surgical revision and the reduced life expectancy of this patient population, metallic stent placement represents a viable, short-term treatment option for stenoses within or at the anastomoses of prosthetic grafts. Further evaluation is warranted to compare intragraft stent placement with surgical graft revision.     

Effect on intimal hyperplasia of dexamethasone released from coated metal stents compared with non-coated stents in canine femoral arteries

Purpose: Polymer-coated, dexamethasone (DXM)-releasing stents were tested in order to assess the efficacy of DXM released locally for the prevention of stent restenosis due to intimal hyperplasia. Methods: Strecker stents coated with a biodegradable membrane containing DXM were implanted percutaneously into the femoral artery in 14 dogs. The contralateral artery received a conventional non-coated stent serving as control. The drugs are eluted by degradation of the carrier membrane. Follow-up intraarterial digital subtraction angiography (DSA) was obtained at 3, 6, 9, 12, and 24 weeks with subsequent autopsy. Specimens for gross and microscopic pathology were obtained and histomorphometry was performed. Results: Four of 14 DXM-coated stents showed thrombotic occlusion within the first 3 weeks; ten DXM-coated stents remained patent. At follow-up DSA, DXM-coated stents showed a significantly wider lumen than the non-coated stents. At morphometry there was less intimal hyperplasia over DXM-coated stents than over non-coated stents (p < 0.05). Conclusion: DXM-coated stents reduce neointimal hyperplasia in dogs when compared with non-coated stents.     

Assessment of a Polyester-Covered Nitinol Stent in the Canine Aorta and Iliac Arteries

Purpose: To evaluate the patency and healing characteristics of a woven polyester fabric-covered stent in the canine model. Methods: Twenty-four self-expanding covered stents were placed in the infrarenal aorta and bilateral common iliac arteries of eight dogs and evaluated at 1 (n = 2), 3 (n = 2), and 6 (n = 4) months. Stent assessment was done using angiography prior to euthanasia, and light and scanning electron microscopy. Results: Angiographically, just prior to euthanasia, 8 of 8 aortic and 14 of 16 iliac endovascular covered stents were patent. Histologically, the stented regions showed complete endothelialization 6 months after graft implantation. A neointima had formed inside the stented vessel regions resulting in complete encasement of the fabric-covered stent by 3 months after graft implantation. Medial compression with smooth muscle cell atrophy was present in all stented regions. Explanted stent wires, examined by scanning electron microscopy, showed pitting but no cracks or breakage. Conclusion: The covered stent demonstrated predictable healing and is effective in preventing stenosis in vessels 10.0 mm or greater in diameter but does not completely preclude stenosis in vessels 6.0 mm or less in diameter.     

Are Covered Stents Really Effective at Closing Esophagotracheal Fistulas? Results of an Animal Study

Purpose: To determine whether covered self-expanding metal stents successfully exclude experimentally created esophagotracheal fistulas. Methods: Esophagotracheal fistulas were surgically created in the upper third of the esophagus in 12 minipigs and immediately sealed by implantation of a covered self-expanding metal stent (20 mm expanded diameter) in the esophagus. Before the animals were killed, after 3, 7, 14, 28, 30, and 36 days, the position of the stent and the sealing of the fistula were monitored fluoroscopically. The esophagus, trachea, and both lungs were examined histologically. Results: Creation of an esophagotracheal fistula was successful in all cases. All fistulas were widely patent at autopsy. The technical success rate for stent deployment and initial sealing of the fistula was 100%. During follow-up, five stents migrated distally, but none into the stomach. Therefore, the fistula was no longer excluded in five animals. In seven animals the stent sealed the fistula until the death of the animal. Tracheal narrowing necessitated additional tracheal stenting in three animals. Two minipigs died due to aspiration of food. Histologic examination showed signs of aspiration in all animals with stents in place for longer than 2 weeks. Conclusion: This experimental animal study revealed worse results for sealing of esophagotracheal fistulas with covered self-expanding metal stents than have been reported for the clinical use of these devices.     

Treatment of Complete and Partial Obstruction of the Nasolacrimal System with Polyurethane Stents: Initial Experience

Purpose: To present our experience in the treatment of nasolacrimal occlusion by means of polyurethane stents. Methods: Forty polyurethane stents were placed under fluoroscopic guidance in 35 consecutive patients with epiphora due to total or partial obstruction of the nasolacrimal system. The set designed by Song was used in all patients. The procedure was performed by introducing a guidewire through the superior punctum into the canaliculus and advancing it across the obstruction into the inferior meatus of the nasal cavity. After pulling out the guidewire, the stent was advanced in retrograde fashion and released into the sac and the nasolacrimal duct. Results: The technical success rate was 100%. The average time for the procedure was 25 min (range 10–60 min). Immediate complications were: mild pain (n= 5), severe pain (n= 1), minimal epistaxis (n= 7), and moderate epistaxis (n= 1). No major complications occurred. The last clinical control revealed complete resolution of epiphora in 35 eyes and partial resolution in four; one patient did not improve. Conclusion: This technique for treatment of obstruction of the nasolacrimal system is simple and safe, and may obviate the use of more invasive procedures. Received: 0/00/00/Accepted: 0/00/00     

Treatment of Pelvic Venous Spur (May–Thurner Syndrome) with Self-Expanding Metallic Endoprostheses

Purpose: The application of self-expanding metallic endoprostheses (stents) to treat symptomatic pelvic venous spurs as an alternative to surgery. Methods: Wallstents with a diameter from 14 to 16 mm and one Cragg stent were placed in the left common iliac vein of eight patients (seven women, one man; mean age 42 years) with a symptomatic pelvic venous spur (left deep venous thrombosis or post-thrombotic leg swelling). Four patients had surgical thrombectomy prior to stent placement. Results: Technical success with immediate reduction of left leg circumference was achieved in all eight patients. A primary patency rate of 100% was observed during an average follow-up of 3 years (range 10–121 months). There were no procedural or stent-related complications. Conclusion: The percutaneous transfemoral placement of self-expanding metallic stents is an effective minimally invasive alternative to surgery in the treatment of symptomatic pelvic venous spur. Received: 0/00/00/Accepted: 0/00/00     

Venous recanalization by metallic stents after failure of balloon angioplasty or surgery: Four-year experience

Purpose: This retrospective study describes our updated experience in treating venous stenoses and occlusions with metallic endovascular stents. Methods: Gianturco, Palmaz, and Wallstent stents were placed in 55 patients over a 4-year period. Stent sites included the subclavian veins (9), innominate veins (3), superior vena cava (4), inferior vena cava (3), iliac veins (29), femoral veins (5), and portal veins (6). The most common indications for stent placement were malignant stenoses and chronic pelvic venous occlusions. Venoplasty and/or urokinase were used as ancillary therapy. Patients were anticoagulated for 3–6 months. Follow-up included clinical assessment and duplex ultrasound. Results: Lifetable analysis shows 59%, 63%, and 72% primary, primary assisted, and secondary 1-year patency rates, respectively. The 4-year primary patency rates were the same. Duration of patency depended on the venous site. Death was a complication of stent placement in 2 patients and 12 patients died within 6 months after stent placement from primary disease progression. Although early failures were more common in stents placed across occlusions than stenoses, 1-year secondary patency rates were comparable. Primary patency rates were only slightly lower in patients with malignant obstruction than in patients with benign disease. Conclusion: Endovascular stent placement provides a nonsurgical alternative for reestablishment of venous flow and symptomatic relief in patients with benign as well as malignant venous obstruction. Received: 0/00/00/Accepted: 0/00/00     

Clinical Experience with Covered Wallstents for Biliary Malignancies: 23-Month Follow-Up

Purpose: To evaluate the effectiveness of partially covered metallic Wallstents to prevent tumoral ingrowth in patients with neoplastic obstruction of the biliary tract. Methods: Twenty-one patients with malignant obstructive jaundice have been treated with Wallstents partially covered with a polyurethane polymer. In total, 36 covered stents (8 and 10 mm in diameter, 70 and 90 mm long) were deployed. All the stents were free from covering at both ends. Results: Jaundice was successfully treated in 100% of cases. There were no problems related to the releasing system during stent positioning, no major complications, and no incompatibility reactions to the materials composing the endoprostheses. At 23-month follow-up, 6 patients are still alive and 15 are dead; of these 15 patients, 11 died in the first 6 months and the last 4 died between 6 and 23 months. Seven patients had an obstructed stent; in four of these, cholangioscopy showed the presence of tumoral ingrowth and in one it showed necrotic tissue with biliary pigments and inflammatory cells. No biopsy specimen was obtained in the remaining two patients with stent obstruction. The follow-up, ranging from 7 to 23 months, showed a primary patency of 46.8% and 24.6% and an assisted patency of 66.3% and 59% at 6 months and 23 months, respectively. Conclusions: Covered metallic stents are effective and may produce improved survival in patients with malignant biliary obstruction (27.8% at 23 months). Stent patency, however, is similar to that of uncovered stents. Modifications in the design of the covering membrane may reduce stent obstruction resulting from disruption of the plastic covering. Received: 0/00/00/Accepted: 0/00/00     

Duplex ultrasonography in assessing restenosis of renal artery stents

Purpose: To determine the accuracy and optimal threshold values of duplex ultrasonography (US) in assessing restenosis of renal artery stents. Methods: Twenty-four consecutive patients with 33 renal arteries that had previously been treated with placement of a Palmaz stent underwent duplex US prior to intraarterial digital subtraction angiography (DSA), which was the reference standard. Diagnostic accuracy of in-stent peak systolic velocity (PSV) and reno-aortic ratio (RAR = PSV renal stent/PSV aorta) in detecting > 50% in-stent restenosis were evaluated by the receiver operating characteristic curve. Sensitivity and specificity were determined using the optimal threshold values, and using published threshold values: RAR > 3.5 and in-stent PSV > 180 cm/sec. Results: Six examinations were technically inadequate. Nine stents had residual or restenosis > 50% at DSA. The two duplex parameters were equally accurate since areas under the curves were similar (0.943). With optimal threshold values of 226 cm/sec for PSV and 2.7 for RAR, sensitivities and specificities were 100% and 90%, and 100% and 84%, respectively. Using the published duplex criteria resulted in sensitivities and specificities of 100% and 74% for PSV, and 50% and 89% for RAR. Conclusion: Duplex US is a sensitive modality for detecting in-stent restenosis if laboratory-specific threshold values are used.     

Primary stenting for complex atherosclerotic plaques in aortic and iliac stenoses

Purpose: To evaluate the efficacy of primary stenting for complex atherosclerotic plaques in aortic and iliac stenoses that are not amenable to balloon angioplasty alone. Methods: Nineteen patients with complex atherosclerotic plaques were treated with a Palmaz stent (n= 19), Wallstent (n= 1), Strecker stent (n= 1), or Memotherm stent (n= 1). A total of 22 stenoses presenting with complex plaque morphology including ulcerated plaques, ulcerated plaques with focal aneurysms, plaques with heavy calcification, severely eccentric plaques, plaques with overhanging edge, and plaques with spontaneous dissection were stented. The lesions were in the aorta (n= 1), common iliac artery (n= 19), or external iliac artery (n= 2). Results: Immediate angiography after stent placement revealed restoration of patency of the stented segment. Focal aneurysms and ulcerated areas were occluded in the follow-up angiographies obtained 4–12 weeks after the procedure. In one case with poor distal runoff and multiple complex lesions of the iliac artery, subacute occlusion occurred. Clinical and angiographic follow-up (3–46 months) revealed patency of all other stented segments. Conclusion: Primary stenting is an effective and reliable approach for complex plaques in stenoses. Patency of the arterial segment with a smooth lumen can be created without the risk of acute complications such as distal embolization, dissection, or occlusion.     

Acute and long-term effects of massive balloon dilation on the aortic wall and vasa vasorum

To investigate the acute and long-term effects on the vasa vasorum after massive overdilation, canine aortic segments were dilated with Gruentzig balloon catheters to more than 100% over normal size. In the acute study, the significant lumen increase was the result of intimal and medial rupture with stretching and thinning of the adventitia. In these areas, the vasa vasorum were stretched and severed, causing adventitial hemorrhage. In the chronic study, areas of previous subtotal wall rupture with adventitial thinning were repaired by scar tissue. This repair included formation of a neomedia, hyperplasia of the adventitia, and proliferation of the vasa vasorum. No progression of luminal dilatation was seen. This study showed that in subtotal aortic wall rupture, even a severely damaged adventitia is capable of preserving the lumen from further dilatation and rupture until healing. Blood flow to the damaged vessel wall was reestablished by revascularization via capillary budding in the aortic wall.     

Low-molecular-weight heparin (reviparin) reduces the incidence of femoropopliteal in-stent stenosis: Preliminary results of an ongoing study

Purpose: To examine the efficacy of the low-molecular-weight heparin, reviparin, for prevention of femoropopliteal stent restenosis. Methods: Forty-two patients who had implantation of flexible tantalum stents for the treatment of stenosis (n= 24) or occlusion (n= 18) of the femoral (n= 27) or popliteal (n= 15) arteries were included in this study protocol. An intraarterial bolus of 5000 IU heparin was given before percutaneous transluminal angioplasty (PTA), and in the case of stent implantation due to unsuccessful PTA, an additional dose of reviparin (3500 anti-factor Xa IU) was given. Postprocedurally, 10,500 anti-factor Xa IU of reviparin were administered intravenously over 24 hr, followed by 3500 anti-factor Xa IU subcutaneously twice a day for 23 days. Oral aspirin (100 mg/day) was prescribed for the long term. Follow-up criteria (maximum follow-up 37 months) were clinical symptoms, Doppler ankle arm indices, color and duplex sonography, and angiography for suspicion of restenosis. Results: Early stent thromboses were not observed. Overall primary patency rate (PPR) was 88% ± 6.0% (1 year) and 74% ± 10.1% (2 years). Major hemorrhagic complications have not occurred. Conclusion: Reviparin administered in a high dose over a period of 24 days is a safe medication regimen and provides excellent patency rates after stent implantation.     

Magnetic resonance angiography of nonferromagnetic lliac artery stents and stent-grafts: A comparative study in sheep

Purpose: To compare nonferromagnetic iliac artery prostheses in their suitability for patency monitoring with magnetic resonance angiography (MRA) using conventional angiography as a reference. Methods: In experiment 1, three Memotherm stents were inserted into the iliac arteries of each of six sheep: two “tandem” stents on one side and a single stent on the other side. In experiment 2, four prostheses (normal and low-porosity Corvita stent-grafts, Memotherm, ZA-stent) were inserted in each of 11 sheep. Patency was monitored before and 1, 3, and 6 months after insertion with 3D phase-contrast and two 2D time-of-flight sequences (TOF-1: TR/TE = 18/6.9, TOF-2: 13/2.5) with and without contrast at 1.5 T. On 206 coronal MIP images (72 pre-, 134 post-stenting), three readers analyzed 824 iliac segments (206 × 4) for patency and artifacts. Results: There was no difference in the number of artifacts between tandem and single iliac Memotherm stents. The ZA-stent induced significantly fewer artifacts than the other prostheses (p < 0.00001). With MRA, patency of the ZA-stent was correctly diagnosed in 88% of cases, which was almost comparable to nonstented iliac segments (95%), patency of the Memotherm stent in 59%, and of the Corvita stent-grafts in 57% and 55%. The TOF-2 sequence with contrast yielded the best images. Conclusion: MRA compatibility of nonferromagnetic prostheses depends strongly on the design of the device. MRA may be used to monitor the patency of iliac ZA-stents, whereas iliac Memotherm stents and Corvita stent-grafts appear to be less suited for follow-up with MRA.     

Endoluminal Treatment of Ruptured Abdominal Aortic Aneurysm with Small Intestinal Submucosa Sandwich Endografts: A Pilot Study in Sheep

Purpose: To evaluate efficacy of small intestinal submucosa (SIS) Sandwich endografts for the treatment of acute rupture of abdominal aortic aneurysms (AAA) and to explore the short-term reaction of the aorta to this material. Methods: In eight adult sheep, an infrarenal AAA was created transluminally by dilation of a short Palmaz stent. In six sheep, the aneurysm was then ruptured by overdilation of the stent with a large angioplasty balloon. Two sheep with AAAs that were not ruptured served as controls. A SIS Sandwich endograft, consisting of a Z stent frame with 5 bodies and covered inside and out with SIS, was used to exclude the ruptured and non-ruptured AAAs. Follow-up aortography was done immediately after the procedure and before sacrifice at 4, 8, or 12 weeks. Autopsy and histologic studies followed. Results: Endograft placement was successful in all eight sheep. Both ruptured and non-ruptured AAAs were successfully excluded. Three animals with AAA rupture developed hind leg paralysis due to compromise of the arterial supply to the lower spinal cord and were sacrificed 1 day after the procedure. In five animals, three with rupture and two controls, follow-up aortograms revealed no aortic stenoses and no perigraft leaks. Gross and histologic studies revealed incorporation of the endografts into the aortic wall with replacement of SIS by dense neointima that was completely endothelialized in areas where the endograft was in direct contact with the aortic wall. In central portions of the endograft, in contact with the thrombosed aneurysm, endothelialization was incomplete even at 12 weeks. Conclusion: The SIS Sandwich endografts effectively excluded simple AAAs and ruptured AAAs. They were rapidly incorporated into the aortic wall. A detailed long-term study is warranted.     

Access-Related venous stenoses and occlusions: Treatment with percutaneous transluminal angioplasty and dacron-covered stents

Purpose: To determine the effectiveness of using Dacron-covered stents to treat access-related venous stenoses and occlusions. Methods: Twenty-two Dacron-covered stents were placed in 20 patients: in the basilic or axillary vein (n = 2), cephalic vein (n = 3), subclavian vein (n = 5), and at the venous anastomosis of the polytetrafluoroethylene (PTFE) implant graft (n = 10). Results: Initial technical success was 100%. The cumulative primary and secondary patency rates were 57% and 83% at 6 months, 29% and 64% at 12 months, and 29% and 53% at 18 months. A statistically significant difference in the stent patency was revealed by comparing the patients with stents in the subclavian vein and patients with upper arm stents. The secondary patency rates of the upper arm stents were 73% after 6, 12, and 18 months. Conclusions: Percutaneous placement of Dacron-covered stents is a safe and effective procedure for salvage of a dialysis fistula. First results are promising, with a tendency to prolongation of the time interval between reinterventions.     

Single and tandem stents in sheep iliac arteries: Is there a difference in patency?

Purpose: To compare patency and neointima formation of single and tandem arterial stents. Methods: In each of six sheep, two Memotherm nitinol stents (tandem stents) were inserted into the external iliac artery on one side and a single stent into the artery on the opposite side. The size of the iliac lumen was assessed in the proximal, middle, and distal segments of the stents by intravascular ultrasound (IVUS) before, immediately after, and 1 month after implantation when the sheep were killed. Neointimal thickness was determined in the proximal, middle, and distal segments of each stent by light microscopy. Results: All stents remained patent. There was no significant difference in lumen and neointimal thickness between single and tandem stents. Cranial tandem stents showed a significantly wider lumen and smaller neointimal thickness than caudal tandem stents. In the proximal and distal segments, the lumen of the stents was significantly smaller and the neointimal thickness greater than in the middle segment; differences in neointimal thickness were significant only between the proximal and the middle segment. Conclusion: In an experimental setting, tandem stents did not interfere with one another with regard to patency and neointima formation when compared with a single contralateral stent. Neointimal thickening after stent insertion seems to be inversely related to the original arterial diameter.     

Evaluation of Silicone as an Endovascular Stent Membrane: In Vivo Canine Studies

Purpose: Comparative evaluation of the biological effects of a silicone-covered stent versus a bare-metal stent, in an animal model. Methods: Twelve stent implants were placed in the iliac arteries of six adult dogs. Each animal received one 8-mm × 20-mm silicone-covered stent (Permalume; Boston Scientific Vascular, Watertown, MA, USA), in the right iliac artery and one Wallstent (Boston Scientific Vascular) of the same diameter and length in the left iliac artery, during systemic anticoagulation. Angiography was performed before and after implantations. Animals were then allowed to recover and no platelet suppression was given during a 6-week interval, after which the animals were euthanized. The stented arteries were isolated and pressure-fixed in situ with 10% buffered formalin at a pressure of approximately 100 mmHg for a period of 1 hr. Two of 12 stented specimens were opened lengthwise and the luminal surfaces were photographed. Ten of 12 stented arterial segments were encased in methacrylate, then stained with hematoxylin and eosin. Neointimal thickness was quantified on histologic cross-section, for both bare and covered stents. The mean neointimal thicknesses were compared for significant difference using a student t-test. Results: All implants were widely patent at 6-week follow-up angiography. Histologic analysis showed bare metal stents covered by a thin uniform lining of neointima composed of smooth muscle cells in a hyaline matrix (mean thickness of 189 ± 47 μm). Silicone covered stents were devoid of neointima. There was no chronic thrombus or mature endothelium noted anywhere upon the internal silicone surfaces of any of the specimens. There was no foreign body reaction to the silicone cover. Conclusion: Short-term implantation of a silicone-lined Wallstent in canine iliac arteries is well tolerated. Silicone appears to be inert at 6 weeks in this experimental application.     

Percutaneous Endoluminal Stent and Stent-Graft Placement for the Treatment of Femoropopliteal Aneurysms: Early Experience

Purpose: To determine the efficacy of percutaneous endoluminal stents and stent-grafts for the treatment of isolated femoropopliteal aneurysms. Methods: Seven men (age 51–69 years) with femoropopliteal occlusions (n= 6) related to aneurysms and a patent femoropopliteal aneurysm (n= 1) were treated percutaneously. In two patients uncovered Wallstents and in five patients polyester-covered nitinol stents were implanted. Assessment was performed with Doppler ultrasound and duplex ultrasonography 24 hr, 1, 3, 6, 12, and 24 months after the intervention. Additionally, intraarterial angiography was performed at 6 months. Results: Stent placement succeeded in all cases. No immediate adjunctive surgical treatment was necessary. Ankle-brachial index (ABI) improved from 0.29 ± 0.29 (SD) before to 0.78 ± 0.23 (SD) 24 hr after the intervention. One patient was lost to follow-up. Stent-graft occlusion occurred in four patients: after 2 days (n= 1), 1 month (n= 2), and 3 months (n= 1). One of the patients, whose stent occluded at 1 month, underwent successful recanalization with local fibrinolysis therapy. Three of the seven, all with three-vessel run-off, demonstrated patency of the stent, which was assessed by duplex ultrasonography at 29, 31, and 34 months. Breaking of the stent struts or significant stent migration was not observed. Conclusions: These results in a small number of patients warrant further investigation to evaluate the role of percutaneous stents in femoropopliteal aneurysms. Until further data of clinical studies are available, this method cannot be recommended, and it cannot replace surgical treatment.     

First Experimental Results with a New Type of Stent: The Double-Coil Device

Purpose: To introduce a new stent design and evaluate its technical properties. Methods: This stent consists of two nitinol wires partially connected to each other. After delivery through a catheter a tube-like helical stent forms within the artery. After experimental tests in flow models regarding mechanical properties, introduction and delivery technique, 15 stents were implanted into iliac, femoral, and carotid arteries of seven dogs. After 3–12 weeks angiographic follow-up stents were explanted for microscopic examination. Results: Stents with expanded diameters of 5–10 mm can be introduced through a 5 Fr catheter with 0.038 inch luminal diameter. Thrombotic vessel occlusion was observed in one iliac artery after incorrect stent placement with diameter mismatch. Fourteen of 15 stents remained patent and revealed minor intimal hyperplasia in the areas of the stent strut connection points as well as some reduction in medial thickness. Conclusion: This new stent design has a small introduction diameter which is independent of the expanded diameter. The stents principal characteristics may serve as a basis for further special developments.