Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
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
- 2
- 主要终点
- Primary Patency
研究概览
简要总结
The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.
详细描述
The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:
- the need for re-dilatation of the previously treated vessel segment
- an ultrasound examination The safety of the IN.PACT Admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.
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
- None
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
- •General Inclusion Criteria:
- •Age ≥18 years and ≤85 years
- •Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form
- •Angiographic Inclusion Criteria:
- •Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)
排除标准
- •Patient unwilling or unlikely to comply with follow-up schedule
- •Stroke or STEMI within 3 months prior enrolment
- •Angiographic Exclusion Criteria:
- •Acute or sub-acute thrombus in the target vessel
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 revascularization (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
- Primary Sustained Clinical Improvement(12 month)
- Procedural Success(Day 1)
- All-cause Death(12 month)
- Target Vessel Revascularization (TVR)(12 month)
- Target Lesion Revascularization (TLR)(12 month)
- Major Target Limb Amputation(12 month)
- Major Adverse Events (MAE) Composite(12 month)
- Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)(12 month)
- Thrombosis at the Target Lesion(12 month)
- Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).(12 month)
- Device Success(Day 1)
- Secondary Sustained Clinical Improvement(12 month)
- Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12(Baseline to 12 month)
- Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).(12 month)
- Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months(12 month)
- Clinical Success(Day 1)
- Days of Hospitalization Due to the Index Lesion(12 month)