Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion
研究概览
简要总结
Multicentre prospective registry including consecutive patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in which variables related to the percutaneous access closure for implanting devices at aorta level will be collected and analyzed.
The follow-up period will be 30 days after the procedure. The duration of the recruitment period will be one year. All data will be collected telematically and incorporated into a database for subsequent statistical analysis.
There will be 2 points for data interim analysis at 6 and 12 months after initiation of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Men and women over 18 years old
- •Signed informed consent
- •Endovascular procedures on the aorta to any level, performed by percutaneous access and requiring the use of devices ≥ 10F
- •Femoral Access suitable for percutaneous treatment in the opinion of the surgeon
排除标准
- •Need for surgical repair of the femoral artery (stenosis aneurysmal)
- •Initial indication of percutaneous closure with another device different from the Perclose Proglide
- •Active infection of the puncture site
- •Condition that prevents complete the 30 days follow up
结局指标
主要结局
Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion
时间窗: 30 days
Rate of cases that are reported with a femoral pseudoaneurysm in the site of arterial access or common femoral artery occlusion related to the closure procedure.
Incidence of Procedure-Emergent Adverse Events related to Frailty as assessed by the Modified Frailty Index (mFI-11)
时间窗: 30 days
Incidence of any postoperative adverse event or mortality related to the frailty assessed by the modified frailty index (mFI-11), an 11-factor score predictive of increased risk for postoperative morbidity and mortality in patients undergoing elective and emergent surgery that scores the frailty between 1 to 11, being the 11 the most frailty status.
Quality of Life assesed by EuroQol-5 Dimensions (EQ-5D) Questionnaire
时间窗: 30 days
Estimated Impact of the procedure on the Quality of Life measured by EQ-5D Questionnaire on 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The study participants self-rate their level of severity for each dimension. Rated level can be coded as 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
次要结局
- Post-operative Pain assessed by the Visual Analog Scale for Pain(30 days)
- Time of closure procedure hemostasis in seconds(1 hour)
- Hospital Stay assessed in days(30 days)