Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 279
- 试验地点
- 24
- 主要终点
- Primary patency at 6 months
研究概览
简要总结
This study aims to conduct a randomized, double blind, randomised controlled multicentre trial of sirolimus drug coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial and popliteal arterial disease.
详细描述
The burden of limb loss as a result of peripheral arterial disease (PAD) is high and this problem is set to worsen globally. Treatment of PAD primarily involves revascularisation of the limb. Angioplasty as a first line strategy of revascularization over surgical procedures has been adopted by most vascular centers. Local drug delivery using drug coated balloons (DCB) during angioplasty for PAD can successfully deliver effective local tissue concentrations of anti-proliferative drugs to the lesions in the artery involved in the PAD. This offers the potential for sustained anti-restenotic efficacy.
Randomized trials have shown superiority of Paclitaxel DCBs over just plain-balloon angioplasty for treatment of PAD, and DCB is now considered the standard of care. However a recent meta-analyses which showed increased mortality at two years in patients treated with paclitaxel DCBs have called into question the safety of paclitaxel based DCBs.
Alternative drugs for DCBs are therefore urgently needed and sirolimus offers an attractive alternative. Compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and has been shown to effectively inhibit neointimal hyperplasia in the porcine coronary model. In the coronary artery interventions, preliminary clinical studies using Sirolimus DCBs have also shown excellent procedural and 6 month patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years or minimum age
- •Rutherford class 3 to 6 in the target limb
- •Intraoperative Inclusion Criteria
- •Single or sequential de novo or re-stenotic lesions (stenosis of > 50% or occlusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered as one lesion if there is maximum of 30mm gap between lesions at discretion of investigator. Femoropopliteal arteries are superficial femoral artery, popliteal artery P1 and P2
- •Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (>50% stenosis) can be included if lesion had been treated successfully (<30% residual stenosis) before or during the index procedure.
- •At least one non-occluded crural vessel (ie. without significant stenosis) with angiographically documented run off to the foot.
排除标准
- •Comorbid conditions limiting life expectancy ≤ 1 year
- •Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- •Subject is pregnant or planning to become pregnant during the course of the study
- •Heel gangrene
- •Prior bypass surgery of target vessel
- •Planned amputation of the target limb
- •Previously implanted stent in the target lesion
- •Vulnerable or protected adults
- •Bleeding diathesis or another disorder such as gastrointestinal ulceration which restrict the use of clopidogrel or aspirin
- •Known allergy to sirolimus
- •Intraoperative Exclusion Criteria
- •Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)
- •Failure to obtain <30% residual stenosis in a pre-existing lesion
- •Highly calcific lesions
- •Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices during the index procedure. (Non-compliant balloons are not considered specialty balloons)
- •Lesions requiring retrograde access (SAFARI)
结局指标
主要结局
Primary patency at 6 months
时间窗: 6 Months
Primary patency rate at 6 months defined as proportion of subjects with duplex ultrasonography-derived peak systolic velocity ratio of \< 2.4 (in absence of target lesion revascularisation)
次要结局
- Amputation-free survival(6, 12 and 24 Months)
- Device and procedure related death(1, 6, 12 and 24 Months)
- Proportion of subjects who are free from clinically-driven Target Lesion Revascularization (TLR)(6,12 and 24 Months)
- Subjects who are free from MAE(6 Months)
- Occurrence of adverse events (AEs), serious AEs and AEs related to device and Occurrence of adverse events (AEs), serious AEs and AEs related to device and procedure(From Day 0 to 24 Months Follow-up)
- All-cause death(1, 6, 12 and 24 Months)
- Major target limb amputation(1, 6, 12 and 24 Months)
- Procedural Success(From Day 1 to discharge up to maximum of 30 days)
- Proportion of subjects who are free from clinically-driven Target Vessel Revascularization (TVR)(6,12 and 24 Months)
- Primary patency(12 and 24 Months)
- Restenosis(6, 12 and 24 Months)
- Clinical Success(6, 12 and 24 Months)
- Device success(Day 1)
- Target vessel thrombosis(From day 0 to day 14)
- Proportion of subjects who experienced either death at 6 month or major target limb amputation at 6 month or target vessel thrombosis within 14 days(Day 0 to day 14, 6 Months)
- Wound assessment (if any)(1, 6, 12, 24 Months)
- Toe Pressure or ABPI assessment(6, 12, 24 Months)
- Technical success(Day 1)