SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 18
- 主要终点
- optimal hemostasis
研究概览
简要总结
The purpose of the Study is to compare the outcomes of the surgical and the percutaneous approach to the upper extremity access (axillary or brachial artery) during endovascular procedures on the aortic valve, the aorta, and its side branches.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Patients who received a surgical or percutaneous access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting, between January 2010 and May 2020
- •Adult patients ≥18 years
排除标准
- •Introducer sheath internal diameter (ID) used < 5F or > 22F
- •Patient with previous surgical axillary access on the puncture side (Pacemaker excluded)
- •Patient with subclavian / axillary / brachial occlusive disease with stenosis greater than 50%
- •Patient with previous bypass surgery or stent placement in the vicinity of access site (ie. Axillary extracorporeal cannulation with, axillo-femoral bypass, patch (venous or synthetic repair of previous axillary access, etc)
- •Bleeding diathesis or coagulopathy
- •Patients with active systemic or cutaneous infection or inflammation
- •Patients who are pregnant or lactating
- •Patient younger than 18 years of age
- •Patients who are morbidity obese (BMI > 40 Kg/m2)
结局指标
主要结局
optimal hemostasis
时间窗: 30 days
Closure success rate of the procedure without any adjunctive procedures
vascular complications
时间窗: 30 days
freedom from major access vascular complications requiring adjunctive endovascular or open procedures
Incidence of permanent peripheral nerve injury
时间窗: 30 days
freedom from permanent peripheral nerve injury with functional compromise
stroke Incidence
时间窗: periprocedural
freedom from periprocedural stroke
Durability of vessel closure
时间窗: 30 days
freedom from secondary intervention at access site
次要结局
未报告次要终点
研究者
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele