NCT02118532已完成不适用
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Medtronic Endovascular15 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 15
- 主要终点
- Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
研究概览
简要总结
The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 85 years.
- •Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
- •Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion
- •Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate.
- •Subject able to walk without assistive devices (e.g. walker, cane).
- •If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure
- •Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as < 50% diameter stenosis).
- •Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
- •Signed and dated Patient Informed Consent (PIC) form.
- •Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
- •Life expectancy, in the Investigator's opinion, of at least 12 months.
排除标准
- •In the investigator's opinion subject is unlikely to comply with the followup schedule.
- •Stroke or STEMI within the 3 months prior to index procedure.
- •Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.
- •Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
- •Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
- •Breastfeeding woman.
- •Chronic renal insufficiency with serum creatinine > 2.5 mg/dL within 14 days prior to index procedure.
- •WBC < 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.
- •PLT count < 80,000 cells/mm3 or > 700,000 cells/mm3 within 14 days prior to index procedure.
- •Known or suspected active systemic infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.
- •Diagnosed with bleeding diatheses or hypercoagulable state.
- •Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.
- •Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.
- •Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
- •Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
- •Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.
- •Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.
- •Failure to successfully cross the target lesion with a guide wire
- •Lesion within or adjacent to an aneurysm.
- •Acute or sub-acute thrombus in the target vessel.
- •Angiographic evidence of severe calcification
- •Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
- •Pre-dilation resulted in a major ( ≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 70% and translesional peak gradient > 10mm Hg.
结局指标
主要结局
Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
时间窗: 12 months
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
Primary Safety Endpoint
时间窗: 30 days post-index procedure
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure
次要结局
- Death of any cause(30 days, 6 and 12 months)
- Target Lesion Revascularization(30 days, 6 and 12 months)
- Major Adverse Events(12 months)
- Target Vessel Revascularization(30 days, 6 and 12 months)
- Major target limb amputation(30 days, 6 and 12 months)
- Thrombosis at the target lesion site(30 days, 6 and 12 months)
- Time to first clinically-driven Target Lesion Revascularization(12 months)
- Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion(6 and 12 months)
- Primary sustained clinical improvement(6 and 12 months)
- Secondary sustained clinical improvement(6 and 12 months)
- Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion(6 and 12 months)
- Walking capacity assessment(30 days, 6 and 12 months)
- Walking distance(30 days, 6 and 12 months)
- Quality of life assessment(30 days, 6 and 12 months)
- Device success(Post procedure)
- Procedural success(Post procedure)
- Clinical success(Post procedure)
- Days of hospitalization due to the target lesion(6 and 12 months)
研究者
研究点 (15)
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