NCT04299906进行中（未招募）不适用
Physician-Initiated PMCF Trial Investigating the Solaris Vascular Stent Graft for the Treatment of Iliac Lesions - SOLARIS Peripheral PMCF Trial
Dr. Sabrina Overhagen16 个研究点 分布在 3 个国家目标入组 70 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Primary Patency Rate at 12 month follow-up
研究概览
简要总结
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
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
- •Corresponding to the IFU indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
- •Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
- •Patient presenting a score from 2 to 5 following Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
- •Patient is >18 years old
- •Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- •The target lesion is either a modified TASC-II class A, B, C or D lesion.
- •The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
- •There is angiographic evidence of a patent Common and Deep Femoral Artery
排除标准
- •PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
- •Presence of an aneurysm immediately adjacent to the site of stent implantation
- •Stenosis distal to the site of stent implantation
- •Lesions in or adjacent to essential collaterals(s)
- •Lesions in locations subject to external compression
- •Heavily calcified lesions resistant to PTA
- •Patients with diffuse distal disease resulting in poor stent outflow
- •Patients with a history of coagulation disorders
- •Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
- •Fresh thrombus formation
- •Patients with known hypersensitivity to the stent material (L605) and/or PTFE
- •The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement.
- •Previously implanted stent(s) at the same lesion site
- •Reference segment diameter is not suitable for the available stent design
- •Untreatable lesion located at the distal outflow arteries
- •Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
- •Patients refusing treatment
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with a history of prior life-threatening contrast medium reaction
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than twelve months
- •Any planned surgical intervention/procedure within 30 days of the study procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
结局指标
主要结局
Primary Patency Rate at 12 month follow-up
时间窗: 12 months post-op
次要结局
- Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up(1day, 1 month, 6 month and 12 month post-op)
- Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI(1-, 6- and 12-month post-op)
- Primary Patency Rate at 1- and 6 month follow-up(1 monthand 6 months post-op)
- in-stent restenosis rate at 1-, 6- and 12-month post-op(1-, 6-, 12-month post-op)
- Performance success rate at baseline(during procedure)
- Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op(1-, 6- and 12-month post-op)
- Technical success rate(during procedure)
- Clinical success at follow-up(1-, 6- and 12-month post-op)
- Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee(1-, 6- and 12-month post-op)
- Serious Adverse Events (SAE's) until 12-month post-op(within 12-months post-op)
研究者
Dr. Sabrina Overhagen
Study Director
FCRE (Foundation for Cardiovascular Research and Education)
研究点 (16)
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