The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,535
- 试验地点
- 120
- 主要终点
- Clinical Cohort ITT - Primary Effectiveness Endpoint
研究概览
简要总结
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
详细描述
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.
The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
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
- •General inclusion Criteria:
- •Age ≥ 18 years or minimum age as required by local regulations.
- •Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-
- •Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
排除标准
- •High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
- •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).
- •Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
结局指标
主要结局
Clinical Cohort ITT - Primary Effectiveness Endpoint
时间窗: 12 months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Primary Safety Endpoint
时间窗: 12 months
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Imaging Cohort ITT - Primary Effectiveness Endpoint
时间窗: 12 months
Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
时间窗: 12 months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
次要结局
- Clinical Cohort ITT - MAEs(48 Months)
- Clinical Cohort ITT - TLR(48 Months)
- Clinical Cohort ITT - TVR(6 Months)
- Clinical Cohort ITT - Device Success(Index-procedure)
- Clinical Cohort ITT - Clinical Success(prior to discharge)
- Clinical Cohort ITT - Clinically-driven TLR(48 Months)
- Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)(60 months)
- Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.(60 months)
- Clinical Cohort ITT - Primary Sustained Clinical Improvement(36 Months)
- Clinical Cohort ITT - Secondary Sustained Clinical Improvement(36 Months)
- Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure(Post procedure)
- Clinical Cohort ITT - Sustained Hemodynamic Improvement(36 Months)
- Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)(36 Months)
- Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)(36 Months)
- Clinical Cohort ITT - Procedural Success(at procedure)
- Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion(at 12 months, or at the time of re-intervention)
- Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion(At 12 months, or at the time of re-intervention)
- 150mm DEB ITT Cohort - MAEs(60 months)
- 150mm DEB ITT Cohort - Clinically-driven TLR(60 months)
- 150mm DEB ITT Cohort - TLR(60 Months)
- 150mm DEB ITT Cohort - TVR(60 Months)
- 150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)(60 months)
- 150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.(60 months)
- 150mm DEB ITT Cohort - Primary Sustained Clinical Improvement(36 months)
- 150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement(36 Months)
- 150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure(Post procedure)
- 150mm DEB ITT Cohort - Sustained Hemodynamic Improvement(36 Months)
- 150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)(36 Months)
- 150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)(36 Months)
- 150mm DEB ITT Cohort - Device Success(Index-procedure)
- 150mm DEB ITT Cohort - Procedural Success(at procedure)
- 150mm DEB ITT Cohort - Clinical Success(prior to discharge)
- Clinical Cohort ITT - All-cause Mortality(60 Months)
- Clinical Cohort ITT - Clinically-driven TVR(60 Months)
- Clinical Clinical Cohort ITT - Clinically-driven TVR(24 Months)
- Clinical Cohort ITT - Major Target Limb Amputation(60 Months)
- 150mm DEB ITT Cohort - All-cause Mortality(60 Months)
- 150mm DEB ITT Cohort - Clinically-driven TVR(60 Months)
- 150mm DEB ITT Cohort - Major Target Limb Amputation(60 Months)