NCT02462005已完成不适用
Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.
Klinikum Arnsberg6 个研究点 分布在 2 个国家目标入组 171 人开始时间: 2015年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 6
- 主要终点
- Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.
研究概览
简要总结
A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.
Interim analysis will be carried out for every 50 subjects enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Patient must be willing to sign a a patient informed consent form.
- •Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
- •Target vessel reference diameter 2.5 to 8 mm.
排除标准
- •Subjects pregnant or planning to become pregnant during the course of the study.
- •Life expectancy of less than 1 year.
- •Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.
结局指标
主要结局
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.
时间窗: 6 Months
Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
时间窗: 12 Months
次要结局
- Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention(6 and 24 Months)
- MAE at 12 and 24 months(12 and 24 Months)
- Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)(Intraoperative)
- Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.(6, 12 and 24 months)
- Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.(6, 12 and 24 months)
- Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score(6, 12 and 24 months)
- Device success, defined as exact deployment of the device according to the IFU (operator assessment)(Intraoperative)
- Procedural success, defined as the combination of technical success and device success(Intraoperative)
- Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)(6, 12 and 24 months)
- Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.(6, 12 and 24 months)
研究者
研究点 (6)
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