Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 4
- 主要终点
- Primary Patency
研究概览
简要总结
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.
详细描述
The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > or equal to 18 years and < or equal to 85 years
- •Documented ischemia with Rutherford classification 2, 3, or 4
- •Target lesion in the SFA and/or PPA
- •Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:
- •70 - 99% occlusion by visual estimate with lesion length > or equal to 4 cm and < or equal to 18 cm
- •100% occlusion by visual estimate with lesion length < or equal to 10 cm
- •Combination lesions must have a total lesion length of > or equal to 4 cm and < or equal to 18 cm with an occluded segment that is < or equal to 10 cm (by visual estimate)
- •Target vessel diameter > or equal to 4 mm and < or equal to 7 mm
- •Angiographic evidence of adequate distal run-off to the ankle
- •Able to walk without assistive devices
排除标准
- •Stroke or heart attack within 3 months prior to enrollment
- •Enrolled in another investigational drug, device or biologic study
- •Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- •SFA or PPA disease in the opposite leg that requires treatment at the index procedure
- •Failure to successfully cross the target lesion
- •Angiographic evidence of severe calcification
- •Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
- •Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- •Chronic kidney disease
研究组 & 干预措施
Drug-Coated Balloon (DCB)
IN.PACT Admiral: Balloon Angioplasty
干预措施: Drug-Coated Balloon (DCB) (Device)
Standard PTA
Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty
干预措施: PTA Balloon: Balloon Angioplasty (Device)
结局指标
主要结局
Primary Patency
时间窗: 12 month
Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.
Primary Safety Composite
时间窗: 12 month
Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.
次要结局
- Target Vessel Revascularization (TVR)(12 month)
- Thrombosis at the Target Lesion(12 month)
- Major Adverse Event (MAE) Composite(12 month)
- All-cause Death(12 month)
- Target Lesion Revascularization (TLR)(12 month)
- Major Target Limb Amputation(12 month)
- Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)(12 month)
- Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)(12 month)
- Device Success(Day 1)
- Primary Sustained Clinical Improvement(12 month)
- Secondary Sustained Clinical Improvement(12 month)
- Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)(12 month)
- Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)(12 month)
- Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)(12 month)
- Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)(From baseline to 12 month)
- Procedural Success(Day 1)
- Clinical Success(Day 1)
- Days of Hospitalization Due to the Index Lesion(12 month)