NCT04584632招募中不适用
A Clinical Evaluation of the Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
Efemoral Medical, Inc.8 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2020年9月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Major Adverse Event (MAE)
研究概览
简要总结
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
详细描述
The EFEMORAL I study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5.5 mm and ≤6.5 mm and lesion length ≤90 mm receiving a single EVSS.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
- •Patient with life expectancy >36 months
- •Females of childbearing potential must have negative pregnancy test
- •Patient is able to provide informed consent
- •Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
- •Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed
- •Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment
- •Reference vessel diameter ≥5.5 mm and ≤6.5 mm
- •Target lesion length ≤90 mm
- •Target lesion with ≥50% DS
- •Inflow artery and popliteal artery free from flow-limiting lesion (DS <50%)
排除标准
- •Hemoglobin <9.0 g/dL
- •WBC <3,000 cells/mm3
- •Platelet count <80,000 cells/mm3 or >700,000 cells/mm3
- •Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)
- •Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT
- •A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated
- •Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy
- •Patient is unable to walk
- •Patient has undergone a percutaneous vascular intervention <30 days prior to the planned index procedure
- •Patient is maintained on chronic hemodialysis
- •Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).
- •Patient has had a myocardial infarction within the previous 30 days of the planned index procedure
- •Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk
- •Patient has unstable angina defined as rest angina with ECG changes
- •Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment
- •Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity
- •Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months
- •Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Patient has ischemic or neuropathic ulcers on either foot
- •Patient has undergone minor or major amputation of either lower extremity
- •Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent
- •Target extremity with an angiographically significant (>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure
- •Acute arterial ischemia of the target extremity
- •Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)
- •Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy
- •Total occlusion (100% DS) of the ipsilateral inflow artery
- •Angiographic evidence of thrombus in the target vessel
- •The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) [e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.]
- •Target lesion is within or adjacent to an aneurysm
- •Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion
- •Target lesion has moderate-to-severe calcification
- •Target lesion with > 30% residual stenosis following pre-dilatation
结局指标
主要结局
Major Adverse Event (MAE)
时间窗: 30 days
Freedom from Binary Restenosis
时间窗: 12 months
次要结局
- Binary restenosis rate(1, 6, 12, 24 and 36 months)
- Ipsilateral extremity revascularization (IER)(1, 6, 12, 24 and 36 months)
- Number of patients with Scaffold thrombosis(through 1 month)
- Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)(1, 6, 12, 24 and 36 months)
- Clinical Success(Up to 2 days after procedure)
- Device Success(Day 0)
- Primary patency rate(1, 6, 12, 24 and 36 months)
- Number of patients with scaffold occlusion(6, 12, 24 and 36 months)
- Rate of Major Adverse Limb Events(through 36 months)
- Rutherford-Becker Clinical Category for the target extremity(1, 6, 12, 24 and 36 months)
- Target lesion revascularization (TLR)(1, 6, 12, 24 and 36 months)
- Ankle-brachial index (ABI) of target extremity(1, 6, 12, 24 and 36 months)
- Limb salvage of target extremity(1, 6, 12, 24 and 36 months)
- Technical Success(Day 0)
研究者
研究点 (8)
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