Peripheral arterial occlusive disease Circulatory System
Conditions
Interventions
Percutaneous transluminal stenting with GORE VIABAHN® endoprosthesis with Propaten bioactive surface vs bare nitinol stent"
Sponsors
Medical University of Vienna (Austria)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lifestyle-limiting claudication or rest pain (meeting angiographic entry criteria) affecting a lower extremity (Fontaine stages II-IV) 2. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board 3. At least 18 years of age 4. Noninvasive lower extremity arterial studies within 45-days prior to study procedure demonstrating resting Ankle-Brachial Index (ABI) ? 0.8 in the study limb 5. If applicable, staged ipsilateral vascular procedure = 14 days prior to study procedure. ABIs must be completed prior to the study procedure a minimum of 14 days after the staged vascular procedure 6. If applicable, vascular treatment on non-study leg for bilateral claudication = 14 days prior to study procedure demonstrating Fontaine stage I in non-study leg at the time of study procedure. ABIs must be completed prior to the study procedure a minimum of 14-days after treatment on the non-study leg 7. Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure 8. Projected life expectancy of greater than three years 9. The ability to comply with protocol follow-up requirements and required testing 10. Angiographic and Lesion Requirements (assessed intraoperatively): a. Multiple stenoses or occlusions totalling >15 cm with or without heavy calcification or recurrent stenoses or occlusions that need treatment after two endovascular interventions (>50% by visual estimate) located in the region beginning 1 cm below origin of the profunda femoris artery and ending 5 cm above the radiographic knee joint. Prior angioplasty, if applicable on the target lesion, must have been performed = 6 months prior to the study procedure b. Orifice and proximal 1 cm of SFA are patent c. Popliteal artery is patent 5 cm proximal to the radiographic knee joint line d. Reference diameter of 4.0?7.5 mm in proximal and distal treatment segments within the SFA e. Angiographic evidence of a minimum of at least one tibial artery runoff to the ankle that does not require intervention f. Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel
Exclusion criteria
Exclusion criteria: 1. Untreated flow-limiting aortoiliac occlusive disease 2. Any previous stenting or surgery in the target vessel 3. Subjects with arterial lesions requiring treatment with device diameters other than 5, 6, 7, or 8 mm 4. Severe ipsilateral common femoral/profunda disease requiring surgical intervention 5. Femoral or popliteal aneurysm 6. Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger?s disease, vasculitis) 7. Tibial artery disease requiring treatment 8. Prior ipsilateral femoral artery bypass 9. Severe medical comorbidities (untreated Coronary Artery Disease [CAD]/Congestive Heart Failure [CHF], severe Chronic Obstructive Pulmonary Disease [COPD], metastatic malignancy, dementia, etc.) or other medical condition that would preclude post-procedural ambulation 10. Popliteal artery vascular access at any time during procedure 11. Serum creatinine >2.5 mg/dL within 45 days prior to study procedure 12. Major distal amputation (above the transmetatarsal) in the study or non-study limb 13. Septicemia 14. Any previously known coagulation disorder, including hypercoagulability 15. Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion) 16. Contraindication to anticoagulation or antiplatelet therapy 17. Known allergies to stent/stent-graft components 18. History of prior life-threatening reaction to contrast agent 19. Currently participating in another clinical research trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy: Primary patency based on color doppler ultrasonography (CDUS) and computed tomographic angiography (CTA) at 1 year post-procedure 2. Safety: Composite of major procedural (30-day) adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Primary assisted patency. Timepoints: 12 and 24 months. 2. Secondary patency. Timepoints: 12 and 24 months. 3. Technical success. Timepoints: Immediately after intervention. 4. Target vessel revascularisation. Timepoints: 12 and 24 months. 5. Target lesion revascularisation. Timepoints: 12 and 24 months. 6. Clinical success. Timepoints: 1 month, 6, 12 and 24 months. 7. Primary composite safety and efficacy endpoint. Timepoints: 1 month and 12 months. 8. Change in ankle-brachial index (ABI). Timepoints: 1, 6, 12 and 24 months. 9. Alternate Peak Systolic Velocity Ratios (PSVR of 2.5 or less). Timepoints: 1, 6, 12 and 24 months. | — |
Countries
Austria, Germany
Outcome results
None listed