Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 414
- 试验地点
- 2
- 主要终点
- Patency rate
研究概览
简要总结
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.
详细描述
This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (≤ 10 cm/ > 10 cm and < 20 cm / > 20 cm and ≤ 30 cm). Each strata will include approximately 138 patients.
The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.
All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month.
Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups:
Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥ 18
- •Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-
- •Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
- •Target lesion length is ≤ 30cm
- •Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
- •Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
- •Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
- •Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
- •A guidewire has successfully traversed the target treatment segment.
排除标准
- •Failure to successfully cross the target lesion
- •Angiographic evidence of severe calcification
- •Presence of fresh thrombus in the lesion.
- •Presence of aneurysm in the target vessel/s
- •Presence of a stent in the target lesion
- •Prior vascular surgery of the target lesion.
- •Stroke or heart attack within 3 months prior to enrollment
- •Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- •Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
- •Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
- •Enrolled in another investigational drug, device or biologic study
- •Life expectancy of less than one year
- •Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- •Rutherford classification of 0, 1, 5 or 6.
结局指标
主要结局
Patency rate
时间窗: 1 year
Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure ) or restenosis with Peak Velocity Ratio \> 2.4 evaluated by Duplex Ultrasound
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
时间窗: 1 year
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
次要结局
- secondary Safety(60 months)
- Walking capacity(6,12,24 months)
- improvement shift in Rutherford classification(6,12,24 months)
- Target Lesion Revascularization (TLR) rate(6,12,24 months)
- binary restenosis(6,12,24 months)
研究者
Dierk Scheinert
Prof. Dr.
University of Leipzig