ISRCTN48164244已完成未知
GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease
Medical University of Vienna (Austria)0 个研究点目标入组 120 人开始时间: 2009年5月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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