Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 16
- 主要终点
- Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate
研究概览
简要总结
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
详细描述
The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age.
- •Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
- •Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations.
- •Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery.
- •De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area.
- •Subject is willing to comply with the required follow up visits, testing schedule and medication regimen.
- •Successful wire crossing of lesion.
- •Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation).
- •Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters.
- •At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography.
- •Life expectancy >1 year
- •Rutherford classification of 2, 3 or 4.
排除标准
- •Pregnant or lactating females.
- •Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- •Known intolerance to study medications, everolimus or contrast agents.
- •Doubts in the willingness or capability of the subject to allow follow-up examinations.
- •Subject is actively participating in another investigational device or drug study.
- •History of hemorrhagic stroke within 3 months of procedure.
- •Previous or planned surgical or interventional procedure within 30 days of index procedure.
- •Prior vascular surgery of the target lesion.
- •Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
- •Known inadequate distal outflow.
- •Significant inflow disease.
- •Acute or sub-acute thrombus in target vessel.
- •Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy).
- •Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
- •Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
- •Rutherford classification of 0, 1, 5 or 6
- •Presence of prohibitive calcification that precludes adequate PTA treatment.
- •Subjects held in custody in an institution by official or court order.
研究组 & 干预措施
Everolimus-coated balloon
Treatment of patients with de-novo or post-PTA occluded/stenotic or re-occluded/restenotic lesions in femoropopliteal arteries with a drug-coated balloon.
干预措施: Peripheral PTA with a drug coated balloon (Device)
结局指标
主要结局
Number and Percentage of Participants With Freedom of Major Adverse Event (MAE) Rate
时间窗: 6 months post procedure
Freedom from MAEs defined as a composite rate of cardiovascular death, index limb amputation, and ischemia-driven TLR.
The Primary Effectiveness Endpoint: Patency (Freedom From Restenosis, Freedom From Ischemia-driven TLR)
时间窗: 6 months post procedure
Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).
次要结局
- Rate of Major Adverse Event (MAE)(12 months Post-procedure)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(12months)
- Rate of Ipsilateral Embolic Events of the Study Limb(12 months)
- Rate of Clinically-driven Revascularization(12 months)
- Patency Rate(12 months)
- Rate of Vascular Access Site Complication(12 months)
- Lesion Success(12 months)
- Technical Success(12 months)
- Clinical Success(12 months)
- Procedural Success(12 months)
- Change in Ankle-Brachial Index (ABI)(12 months)
- Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty(Pre-Procedure to 6 months and 12 months)
- Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed(Pre-Procedure to 6 months and 12 months)
- Walking Test: Change in Walking Distance(Baseline to 6 months and 12 months)
- Treadmill Test: Change in Walking Distance(Baseline to 6 months and 12 months)
- Change in Rutherford Classification(12 months)
- Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment(Pre-Procedure to 6 months and 12 months)