NCT03982940进行中（未招募）不适用
Physician-Initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System as Bridging Stent in BEVAR for Complex Aortic Aneurysms
Marc Bosiers, MD13 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2020年9月9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
- 118
- 试验地点
- 13
- 主要终点
- Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks 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 safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for elective repair of TAAA with BEVAR in accordance with the applicable guidelines for vascular interventions (e.g. Aneurysm size 6cm or aneurysm growth of >5mm within 6 months or 1cm within 1 year)
- •Patient is willing to comply with specified follow-up evaluations at the specified times
- •Patient is >55 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the trial
- •Patient has a projected life-expectancy of at least 12-months
- •Patient needs to have a landing zone in their target vessel of at least 15 mm, and coverage/ wall adaptation of the BGP+ should be obtained for at least 10 mm.
- •The access vessel for introduction of the sheath through which the BGP+ will be advanced should be at least 3mm (it should be able to fit a 8F sheath)
- •No early important division branch from the target vessel with risk of coverage
- •Absence of pre-existing dissection in the target vessels
- •Target vessels (renal arteries, superior mesenteric artery, and celiac trunk) for the BGP+ must have a diameter between 5 and 10 mm
- •Aortic endoprosthesis with inner branches (can be hybrid or branches only)
- •Hybrid aortic endoprosthesis with fenestrations and branches (at least 2 and only the target vessels which are connected by a branch shall be treated with a study device within this study)
- •At least one target vessel is bridged with only one BGP+ (relining allowed)
- •Full compliance with all inclusion criteria/
排除标准
- •and all intraoperative criteria
- •Exclusion Criteria:
- •Previously implanted stent in the target vessel
- •Renal artery with >100° cranial orientation
- •Patients refusing treatment
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients with uncorrected bleeding disorders or heparin induced thrombocytopenia
- •Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding
- •Any planned surgical intervention/procedure within 30 days of the trial procedure
- •Patients with rupture or any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another conflicting investigational drug or device trial that has not completed the entire follow up period.
- •Patients with diffuse distal disease resulting in poor stent outflow
- •Fresh thrombus formation within the last 14 days
- •Patients with known hypersensitivity to the stent material (L605) and/or PTFE
- •Hybrid Approach (endovascular in combination with open surgery)
- •Patients with a connective tissue disorder
- •Patients with mycotic or inflammatory aneurysm
- •Myocardial infarction or stroke within 3 months prior to the procedure
- •Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4
- •Patients with ASA classification 5 or higher
- •Contraindications against contrast enhanced angiography (a.e. massive hyperthyroidism)
- •Patients with increased risk of intraoperative rupture
- •Patients with access vessel which are too tortuous, narrow or any kind of reason that would lead to failure of introducing and advancing an introducer sheath
结局指标
主要结局
Safety endpoint - Absence of procedure related complications and bridging stent related endoleaks at 12 months
时间窗: 12 months post-op
Absence of procedure related complications and bridging stent related endoleaks at 12 months
Efficacy endpoint (1) - Technical success
时间窗: 1 day post-op
defined as successfully introduction and deployment of the BGP+ balloon expandable covered Stent Graft System implanted as bridging stent in BEVAR
Efficacy endpoint (2) - Bridging stent patency at 12 months
时间窗: 12 months post-op
defined as absence of restenosis (≥50% stenosis) or sole target vessel occlusion based on CT angio at 12 months
次要结局
- Bridging stent patency post-procedure(1 day post-op, 6- and 24- months post-op)
- Freedom from type I & III endoleaks post-procedure post-procedure(1 day post-op, 6-, 12-, and 24- months post-op)
- 30-day mortality(30 days post-op)
- Freedom from bridging stent related endoleaks post-procedure(1 day post-op, 6- and 24- months post-op)
- Freedom from bridging stent related secondary intervention(1 day post-op, 6-, 12- and 24- months post-op)
- Freedom from stent graft migration(1 day post-op, 6-, 12 -and 24- months post-op)
- Freedom from AAA diameter increase(6-, 12- and 24- months post-op)
- Freedom from aneurysm related secondary endovascular procedures(1 day post-op, at 6-, 12- and 24- months post-op)
- Freedom from aneurysm related mortality post-procedure(1 day post-op, 6-, 12-, 24- months post-op)
- Health Related Quality of Life scores(12- and 24- months post-op)
- Freedom from conversion to open surgical repair post-procedure(1 day post-op, 6-, 12-, 24- months post-op)
- Freedom from aneurysm rupture post-implantation(up to 12- and 24- months post-op)
- Freedom from any major adverse events post-procedural and at 6 and 12 months(1 day post-op, 6-, 12- and 24- months post-op)
研究者
Marc Bosiers, MD
Director
FCRE (Foundation for Cardiovascular Research and Education)
研究点 (13)
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