NCT01500070已完成2 期
PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Primary patency
研究概览
简要总结
This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated.
In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
- •Patient is willing to comply with specified follow-up evaluations at the specified times
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- •Patient has a projected life-expectancy of at least 12 months
- •The treating physician consider the patient eligible for below-the-knee treatment with the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston Scientific)
- •Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
- •Angiographic Inclusion Criteria:
- •Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk
- •A maximum of two focal target lesions in one or more infrapopliteal vessels
- •Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted
- •Target vessel diameter visually estimated to be >2.5mm and <4.0mm
- •Guidewire and delivery system successfully traversed lesion
排除标准
- •Patient refusing treatment
- •Previously implanted stent in the artery to be treated
- •Failed PTA of target lesion/vessel less than 3 months prior to study procedure
- •The reference segment diameter is not suitable for the available stent design
- •Untreated flow-limiting inflow lesions
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
- •Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
- •Aneurysm in the target vessel
- •Patient presents with renal failure, evidenced by a serum creatinine level >2.0mg/dL
- •Patient presents with platelet levels above or below normal range
- •Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
- •Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- •Septicemia or bacteremia
- •Any previously known coagulation disorder, including hypercoagulability
- •Contraindication to anticoagulation or antiplatelet therapy
- •Known allergies to stent or stent components
- •Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
- •Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- •Currently participating in another clinical research trial
- •Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
- •Target lesion access not performed by transfemoral approach.
结局指标
主要结局
Primary patency
时间窗: 12 months
Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.
次要结局
- Technical success(1 day post-procedure)
- Secondary patency rate(1, 6 and 12 month follow-up)
- Primary assisted patency rate(1, 6 and 12 month follow-up)
- Clinical success at follow-up(1 day, 1 month, 6 month and 12 month follow-up)
- Improvement of ankle-brachial index (ABI)(1 day, 1 month, 6 month and 12 month follow-up)
- Serious Adverse Events (SAE)(1 day, 1 month, 6 month and 12 month follow-up)
- Hemodynamic primary patency rate(1, 6 and 12 month follow-up)
- Limb-salvage(1, 6 and 12 month follow-up)
- Target lesion revascularization (TLR)(1 day, 1 month, 6 month and 12 month follow-up)
研究者
研究点 (16)
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