A prospective, phase 4, open label, multicenter study to evaluate the Zilver PTX Drug-Eluting Peripheral Stent in patients with lesions of the above-the-knee femoropopliteal artery in India ( Zilver PTX VII,India)
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- The 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related
研究概览
简要总结
This multicenter, prospective, single-arm clinical study will evaluate the Zilver PTX Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in an Indian patient population. The above-the-knee femoropopliteal artery is defined as the superficial femoral artery and the popliteal artery above the plane of the femoral epicondyles. The primary endpoint will be 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related major adverse events (death, amputation of the study limb due to target lesion restenosis, clinically driven target lesion revascularization, target limb ischemia requiring surgical intervention due to target lesion restenosis, or surgical repair of the target vessel due to target lesion restenosis).
研究设计
- 研究类型
- 观察性
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4 2.
- Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery 3.
- Reference vessel diameter of 4-7 mm.
排除标准
- Less than 18 years old 2.
- Unwilling or unable to sign and date the informed consent 3.
- Pregnant, lactating, or planning to become pregnant in the next 5 years 4.
- Unwilling or unable to comply with follow-up schedule 5.
- Simultaneously participating in another investigational drug or device study in which the follow-up phase for that study’s primary endpoint has not been completed 30 days or more prior to being enrolled in this study.
- Any interventional treatment within 30 days prior to the study procedure 8.
- Planned surgical or interventional procedure within 30 days after the study procedure 9.
- Planned procedure involving arterial interventional treatment of the study leg within 6 months after the clinical study procedure 10.
- Medical condition or disorder that would limit life expectancy to less than 12 months, or that may cause noncompliance with the study plan or confound the data analysis 11.
- Known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated; study products include nitinol, paclitaxel, dual antiplatelet therapy, and contrast agent 12.
- Current systemic or local infection that could affect the study outcomes 13.
- Previous stent in the target vessel 14.
- Bypass graft with an anastomosis in the target vessel 15.
- Myocardial infarction within the last 90 days 16.
- Is in chronic renal failure, or is on hemodialysis or chronic peritoneal dialysis 17.
- Uncontrolled or poorly controlled diabetes 18.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions 19.
- History of aortic aneurysm 5 cm (treated or untreated) 20.
- History of iliac aneurysm 2 cm (treated or untreated).
- Lesion length 140 mm 22.
- Untreated stenosis ( 50%) or occlusion of inflow tract (i.e., proximal ipsilateral, iliofemoral, or aortic lesions).
- Untreated stenosis ( 50%) or occlusion of all runoff vessels (i.e., anterior tibial, posterior tibial and peroneal).
- Runoff vessel(s) may be treated during the study procedure; treatment must be performed prior to treating the target lesion and result in less than eqal to 30% residual stenosis of at least one runoff vessel.
- Lesions requiring atherectomy (or ablative devices), cutting balloons, or any other advanced device to facilitate stent delivery.
结局指标
主要结局
The 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related
时间窗: 6 months follow up
major adverse events (death, amputation of the study limb due to target lesion restenosis,
时间窗: 6 months follow up
clinically driven target lesion revascularization, target limb ischemia requiring surgical
时间窗: 6 months follow up
intervention due to target lesion restenosis, or surgical repair of the target vessel due to
时间窗: 6 months follow up
target lesion restenosis).
时间窗: 6 months follow up
次要结局
- N/A(N/A)
研究者
研究点 (6)
标识符
- CTRI 编号
- CTRI/2015/11/006374
日期
- 最近更新
- (8年前)