NCT04503395招募中不适用
Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck
FCRE (Foundation for Cardiovascular Research and Education)59 个研究点 分布在 10 个国家目标入组 204 人开始时间: 2021年5月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 59
- 主要终点
- Effectiveness Endpoint - Technical Success
研究概览
简要总结
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
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
- 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
- •Subject is >18 years old
- •Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
- •Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- •Subject has provided written informed consent
- •CT Angiographic Inclusion Criteria
- •Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
- •Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
- •Aortic neck diameter from 19 to 31mm
- •Infrarenal neck angulation ≤45°
排除标准
- •Subject is participating in a concurrent study which may confound study results
- •Subject has a life expectancy <2 year
- •Subject is female of childbearing potential in whom pregnancy cannot be excluded
- •Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
- •Subject with a MI or CVA within 3 months prior to index procedure
- •Subject with known Connective Tissue Disease
- •Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
- •Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
- •Subject requires emergent aneurysm treatment, for example, trauma or rupture
- •Subject has a known hypersensitivity or allergies to study device implant material
- •Subject has an aneurysm that is:
- •Suprarenal, pararenal, or thoracoabdominal
- •Inflammatory
- •Pseudoaneurysm
- •Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential >50%
- •Pre-op stenosis of the renal arteries > 50%
- •Subject has active infection or history of COVID-
- •History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.
研究组 & 干预措施
ESAR
Experimental
Endovascular Aneurysm Repair + Heli-FX EndoAnchors
干预措施: ESAR treatment: Endograft + Heli-FX Endoanchor (Device)
FEVAR
Active Comparator
Fenestrated EndoVascular Aneurysm Repair
干预措施: FEVAR treatment : Fenestrated endograft (Device)
结局指标
主要结局
Effectiveness Endpoint - Technical Success
时间窗: through 12 months post-procedure
Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.
Safety Endpoint - Freedom from Major Adverse Events
时间窗: through 30 days post-procedure
Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss \> 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications
次要结局
- Total contrast volume (ml) at index procedure(at index procedure)
- Total fluoroscopy time (minutes) at index procedure(at index procedure)
- Adequate penetration of EndoAnchor implants as assessed by the Core Lab(at index procedure)
- Duration (minutes) of index procedure(at index procedure)
- Clinical success(through 30 days post-procedure)
- Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up(through 12,24 and 36-months post-op)
- Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up(through 12,24 and 36-months post-op)
- Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up(through 1,12,24 and 36-months post-op)
- Overall SCI rate, include transient events at 1 and 12 months follow-up(through 1 and 12 months post-op)
- Freedom from aortic neck-related secondary interventions(at 1-, 12-, 24- and 36-months follow-up)
研究者
Marc Bosiers, MD
Sponsor
FCRE (Foundation for Cardiovascular Research and Education)
研究点 (59)
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