REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Peak Systolic Velocity Ratio (PSVR)
研究概览
简要总结
Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.
详细描述
The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral artery disease of the femoropopliteal artery.
Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be completed within approximately six months of initiating the study.
One group (DES or DEB) will be considered to yield significantly better results of the primary patency rate than the other group at 12 months follow up.
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 is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
- •A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis might, at the decision of the investigator, be considered as 2 lesions).
- •Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment.
- •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
- •Clinical exclusion criteria
- •Inability to obtain informed consent.
- •Life expectancy < 12 months.
- •Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment).
- •Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure.
- •Any evidence of hemodynamic instability prior to procedure/randomization.
- •Coagulopathy or clotting disorders.
- •Present or suspected systemic infection or osteomyelitis affecting target limb.
- •Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
- •Hypersensitivity to nitinol and/or paclitaxel.
- •Enrollment into another study.
- •Intervention of the target lesion less than 90 days prior of the study procedure.
- •Anatomic Exclusion Criteria:
- •Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures).
- •Total occlusion uncrossable by a conventional guidewire.
- •Acute occlusive intraluminal thrombosis of the proposed lesion site.
- •Evidence of an aneurysm at the target lesion site.
- •Perforation in the target vessel as evidenced by the extravasation of contrast.
结局指标
主要结局
Peak Systolic Velocity Ratio (PSVR)
时间窗: 12 months
The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) \> 2.4 as evaluated by duplex ultrasound core laboratory analysis.
target lesion revascularization (TLR)
时间窗: 12 months
The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) \> 2.4 as evaluated by duplex ultrasound core laboratory analysis.
次要结局
- Major Adverse Events (MAEs)(6, 12 and 24 months)
- All cause death(6, 12 and 24 months)
- Target vessel revascularization (TVR)(6, 12 and 24 months)
- Clinically-driven target lesion revascularization (TLR)(6, 12 and 24 months)
- Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation(6, 12 and 24 months)
- Sustained clinical improvement(6, 12 and 24 months)
- Binary restenosis(6, 12 and 24 months)
- Walking capacity(6, 12 and 24 months)
- Procedural success(6, 12 and 24 months)