A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,005
- 试验地点
- 143
- 主要终点
- Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
研究概览
简要总结
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
详细描述
The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
- •The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •The subject is ≥ 21 years old.
- •The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.
排除标准
- •The subject is unable or unwilling to provide informed consent.
- •The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
- •The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.
结局指标
主要结局
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
时间窗: 12 months post-index procedure
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
时间窗: 30 days post index procedure
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.
次要结局
- Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure(6 , 12, 24, and 36 months)
- Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.(6, 24, and 36 months post index procedure)
- Percentage of Participants With Acute Device and Procedural Success(At time of Index Procedure)
- Percentage of Participants With Primary Patency at 12 Months Post Index Procedure(12 months post-index procedure)
- Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure(6, 12, 24, and 36 Months Post Index Procedure)
- Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.(6, 12, 24, and 36 Months Post Index Procedure)