NCT05406622进行中（未招募）不适用
A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluating the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared With Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 292
- 试验地点
- 30
- 主要终点
- Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
研究概览
简要总结
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
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
- Single (Participant)
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
- •Clinical Inclusion Criteria
- •Subjects must meet all of the following criteria to be eligible for enrollment in the trial:
- •Subject is at least 18 years of age.
- •Subject presents with symptomatic CLI classified as Rutherford category 4 or
- •Subject agrees to comply with all-protocol specified procedures and follow-up assessments.
- •Subject or subject's legal representative signs an IRB/EC approved informed consent form prior to study participation.
- •Angiographic Inclusion Criteria
- •Subjects must meet the following criteria to be eligible for participation in the study:
- •Significant stenosis (>70% diameter stenosis by visual estimate) of one or two native infrapopliteal lesions; if two lesions, each lesion should be in a separate infrapopliteal vessel in the same limb. Unstented restenotic lesions are permitted.
- •Target vessel diameter between 2.5 mm and 3.75 mm and able to be treated with the available device size matrix.
- •Each target lesion is treatable by a maximum of 3 scaffolds, and all target lesions(s) combined must be treatable by a maximum of 4 scaffolds.
- •Total scaffold length among all target lesions must not exceed 120 mm (total sirolimus drug dose of 720 µg).
- •Target lesion(s) must be at least 4 cm above the ankle joint
- •Target lesion(s) are located in an area that may be stented without blocking access to patent main branches.
- •A patent inflow artery from the aorta to the target lesion free from significant stenosis (≥50% diameter stenosis by visual estimate) must be present, as confirmed by angiography.
- •Significant lesions (≥50% diameter stenosis) in inflow arteries must be treated successfully (per physician's assessment) using standard of care treatment prior to enrollment; inflow lesion treatment may be performed during the index procedure.
- •Target vessel(s) reconstitute(s) at or above the ankle or displays normal terminal branching with inline flow to at least one patent (<50% diameter stenosis by visual assessment) outflow vessel.
排除标准
- •Clinical Exclusion Criteria
- •Subjects will be excluded if any of the following criteria apply:
- •Subject has severe medical comorbidities or other medical, social or psychological condition that could limit subject's ability to participate in the study or is associated with a life expectancy of less than 1 year.
- •Subject has documented history of stroke within 3 months prior to the procedure.
- •Subject has history of MI, within 30 days prior to the planned index procedure.
- •Subjects with renal failure (estimated Glomerular Filtration Rate [eGFR] < 30 ml/min).
- •Subject has non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
- •Subject presents with CLI classified as Rutherford category
- •Subject has acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure with associated loss of sensation or motor function.
- •Subject had a major amputation that occurred less than one year prior to enrollment and subject is not independently ambulating.
- •Subject has a planned major amputation (of either leg).
- •Subject has had, or currently requires, surgical revascularization in the target vessel.
- •Subject has a planned use of adjunctive primary treatment modalities (e.g., radiation therapy, stents) in below-the-knee vessels; plaque modification technology such as the use of atherectomy, laser or cutting balloons is permitted.
- •Subject has any systemic infection or immunocompromised state.
- •Subject has a coagulation disorder, including hypercoagulability; or the subject has contraindication to anticoagulant or antiplatelet therapy.
- •Subject has a known history of heparin-induced thrombocytopenia (HIT) type II.
- •Subject has known allergy or sensitivity to scaffold or scaffold components.
- •Subject has a known allergy or sensitivity to contrast media that cannot be adequately pre-treated.
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- •Subject is currently participating in another investigational drug or device clinical study that has not yet met its primary endpoint.
- •Angiographic Exclusion Criteria
- •Subjects will be excluded if any of the following criteria apply:
- •Target lesion(s) with severe calcification (PARC defined).
- •Target lesion(s) will be subjected to significant bending and axial compression.
- •Target lesion(s) located in highly tortuous vessels.
- •Target lesion(s) previously stented (in-stent restenotic lesion).
- •Target vessel(s) has any other significant lesions (≥50% diameter stenosis by visual assessment) that is not a target lesion.
- •Target vessel previously treated within 3 months prior to index procedure
- •Angiographic evidence of thromboembolism in target limb
- •Inflow-limiting arterial stenoses are unsuccessfully treated or left untreated
研究组 & 干预措施
MOTIV Sirolimus-Eluting Bioresorbable Scaffold
Experimental
Participants who receive the MOTIV device will be included in this arm
干预措施: MOTIV Sirolimus-Eluting Bioresorbable Scaffold (Device)
Percutaneous Transluminal Angioplasty (PTA)
Active Comparator
Participants who receive PTA treatment will be included in this arm
干预措施: Percutaneous Transluminal Angioplasty (PTA) Device (Device)
结局指标
主要结局
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
时间窗: 6 Months
Freedom from the composite of above-the-ankle amputation, target lesion occlusion, and clinically driven target lesion revascularization (CD-TLR).
Primary Safety Endpoint: Freedom from Major Adverse Limb Events (MALE) and All-Cause Peri-Operative Death (POD)
时间窗: 30 Days
Freedom from the composite of all-cause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
次要结局
未报告次要终点
研究者
研究点 (30)
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