Physician-Initiated PMCF Trial Investigating the BeGraft Peripheral Stent Graft System for the Treatment of Iliac Lesions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Primary patency at 12 months
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 BeGraft Peripheral Stent Graft System (Bentley InnoMed) in clincial settings post CE-certification when used according to the indications of the IFU.
详细描述
Endovascular techniques are well accepted in the treatment of iliac occlusive disease. It is shown that in the iliac artery especially stenoses and short occlusions respond well to percutaneous transluminal angioplasty (PTA) with our without stenting. Although hard data are lacking, with the technical developments and the introduction of new stent types, more complex lesions have been treated with endovascular procedures. Although stents are often used to improve the outcome of PTA, there is no general consensus whether stenting is mandatory for chronic iliac arterial occlusion. The more, if we use stents, it is still unclear if we should implant bare self-expandable stents, bare balloon-expandable stents or covered stents. On one hand, the randomized controlled Dutch Iliac Stenting trial failed in demonstrating superiority of primary stenting over PTA with additional stenting in short lesions. On the other hand, while several papers advocate bare stenting, other trials conclude better results with covered stents.
The Trans-Atlantic Inter-Society Consensus (TASC) working group has published in 2000 their recommendations for the management of peripheral arterial disease. In order to better reflect the developments in technology and techniques, the TASC working group has revised and updated their recommendations in the TASC-II document in 2007.
The treatment recommendations between surgical or percutaneous intervention they propose involve all peripheral arterial beds and are based upon several factors such as availability of expertise in the percutaneous or conventional vascular surgical techniques, the patient's preference and most importantly on the lesion's morphology. TASC classifies all lesions in the different beds into types A to D. In general, endovascular therapy is the treatment of choice for TASC A & B-lesions and surgery is preferred for good-risk patients with TASC C lesions and all TASC D lesions.
For aorto-iliac lesions, the TASC-II classification is as follows:
Type A lesions
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
- 未提供
排除标准
- 未提供
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 graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up(1 day post-op, 1, 6 and 12 months)
- Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up(1, 6 and 12 months)
- In-stent restenosis rate at 1-, 6- and 12-month follow-up(1, 6 and 12 months)
- Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months(1, 6 and 12 months)
- Serious Adverse Avents(up to 12 months)
- Primary patency rate at 1- and 6-month follow-up(1 and 6 months)
- Technical success(1 day post-op)
- Performance success rate at baseline(1 day post-op)
- Amputation rate at 1-, 6- and 12-month follow-up(1, 6 and 12 months)
- Clinical success at 1-, 6- and 12-month follow-up(1, 6 and 12 months)