ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 86
- 主要终点
- Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
详细描述
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.
排除标准
- •Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
结局指标
主要结局
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
时间窗: 30 Days and 12 months
Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.
Patency at 12 Month Post-procedure
时间窗: 12 months
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
次要结局
- Mortality Rate(6, 12, 24, 36, 48 and 60 months)
- Rate of Vascular Access and Bleeding Complications(in-hospital and 1, 6, 12 and 24 months)
- Rate of Target Lesion Revascularization(6, 12, 24, 36, 48 and 60 months)
- Patency Rate and Freedom From Clinically-driven TLR(6, 24 and 36 months)
- Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%(procedure, Day 0)
- Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure(1, 6, 12, 24, 36, 48 and 60 months)
- Rate of Clinically-driven Target Lesion Revascularization(6, 12, 24, 36, 48 and 60 months)
- Rate of Occurrence of Arterial Thrombosis of the Treated Segment(1, 6, 12, 24, 36, 48 and 60 months)
- Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%(procedure, Day 0)
- Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure(procedure, Day 0)
- Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure(procedure, Day 0)
- Rate of Target Limb Major Amputation(1, 6, 12, 24, 36, 48 and 60 months)
- Change in Ankle-brachial Index (ABI) From Pre-procedure(6, 12, 24 and 36 months)