NL-OMON43996已完成不适用
Tack Optimized Balloon Angioplasty Study for the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System. (TOBA II) - The TOBA II study
Intact Vascular0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •CLINICAL INCLUSION CRITERIA;1. * 18 years
- •3. Target limb requires no additional treatment aside from the target lesion and ipsilateral iliac artery
- •6. Rutherford Classification 2, 3 or 4
- •8. Eligible for standard surgical repair, if necessary
- •9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable);ANGIOGRAPHIC INCLUSION CRITERIA;1. Reference vessel diameter is between 2.5 mm and 6.0 mm, inclusive (by visual estimate)
- •2. Ability to cross a guidewire (antegrade) through target lesion
- •3. Has a de novo or non-stented restenotic target lesion indicated for PTA treatment with a
- •standard or FDA-approved Lutonix drug-coated balloon catheter that meets the following
- •criteria below:
- •a. 70% to 99% stenosis with a total lesion length of *20mm and *150mm in length (by visual estimate) or
- •b.100% occluded with a total lesion length *100mm (by visual estimate)
- •c. A non-stented restenotic lesion must meet the following criteria:
- •i. Meets criteria 3a and 3b
- •ii. No part of the target lesion has been previously treated with a drugcoated
- •iii. No part of the target lesion has had more than 2 previous PTA failures
- •iv. >90 days from most recent angioplasty treatment
- •4.Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee joint) defined as: located *1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal (P1) artery at the superior end of the patella
排除标准
- •CLINICAL EXCLUSION CRITERIA;1. Rutherford Classification 0, 1, 5 or 6
- •2. Is pregnant or refuses to use contraception through the duration of the study
- •3. Previous infrainguinal bypass graft in the target limb
- •8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
- •9. Any other previous or planned surgical or endovascular procedure (not including
- •diagnostic procedures) within 14 days prior to or 30 days post index procedure
- •10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
- •16. Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels.
- •18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint;ANGIOGRAPHIC EXCLUSION CRITERIA:;1. Retrograde access through target limb
- •2. Acute vessel occlusion or acute or sub-acute thrombosis in target lesion
- •3. Subject has significant stenosis (*50% stenosis) or occlusion of ipsilateral inflow iliac artery not successfully treated (<30% residual DS and without complication) prior to PTA of target vessel
- •4. Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable and/or has circumferential calcification
- •5. The target lesion shows no dissections after PTA
- •6. Presence of residual diameter stenosis *30% after PTA (based on visual estimate)
- •7. Non-target limb requiring any vascular treatment at time of index procedure
- •8. Previously implanted stent in the target vessel
研究者
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