NCT02690051已完成4 期
BeSmooth Study, a Physician-initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Primary Patency at 12 months
研究概览
简要总结
A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions.
The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification 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 CE-mark 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
- •Patient is eligible for treatment with the BeGraft Peripheral Stent Graft System (Bentley InnoMed)
- •The target lesion is either a modified TASC-II class A, B, C or D lesion with one of the listed specifications:
- •Type A lesions
- •Unilateral or bilateral stenoses of the Common Iliac Artery
- •Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
- •Type B lesions
- •Unilateral Common Iliac Artery occlusion
- •Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
- •Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
- •Type C lesions
- •Bilateral Common Iliac Artery occlusions
- •Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
- •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 an 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)
- •The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:
- •Type B lesions
- •Short (≤3 cm) stenosis of infrarenal aorta
- •Type C lesions
- •Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery
- •Unilateral External Iliac Artery occlusion that involves the origins of the Internal Iliac and/or Common Femoral Artery
- •Heavily calcified unilateral External Iliac Artery occlusion with or without involvement of origins of the Internal Iliac and/or Common Femoral Artery
- •Type D lesions
- •Infra-renal aortoiliac occlusion
- •Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
- •Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery
- •Unilateral occlusions of both Common Iliac and External Iliac Artery
- •Diffuse disease involving the aorta and both iliac arteries requiring treatment
- •Bilateral occlusions of the External Iliac Artery
- •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
研究组 & 干预措施
BeSmooth Peripheral Stent system
Experimental
Patients treated with the BeSmooth Peripheral Stent System
干预措施: BeSmooth peripheral stent (Device)
结局指标
主要结局
Primary Patency at 12 months
时间窗: 12 months
defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.
次要结局
- Stent Occlusion Rate at 1,6 and 12-month follow-up(up to 12 months)
- Amputation rate at 1,6 and 12-month follow-up(up to 12 months)
- Performance success rate at baseline, defined as restoration of blood flow(during the index study procedure)
- Primary Patency at 1 & 6 month(1 and 6 months)
- ABI at 1,6 and 12-month follow-up, compared with baseline(up to 12 months)
- In-stent restenosis rate(up to 12 months)
- Freedom from Target Lesion Revascularization(up to 12 months)
- Serious Adverse Events(up to 12 months)
- Technical success(during the index study procedure)
- Clinical success at follow-up is defined as an improvement of Rutherford Classification at 1-,6- and 12-month follow-up(up to 12 months)
研究者
研究点 (4)
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