Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

• Conditions: Aorta Dissection; Aortic Coarctation; Aortic Rupture; Aortic Valve Stenosis; Aorta Aneurysm; Aorta Stenosis; Aortic Valve Disease
• Interventions: Device: Perclose Proglide (Abbott)

• Registration Number: NCT04307888
• Lead Sponsor: Sociedad Espanola de Angiologia y Cirugia Vascular

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23
• Study Start: 2020-04
• Primary Completion: 2021-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Perclose Proglide (Abbott)	Patients undergoing Percutaneous Endovascular Aneurysm Repair (PEVAR), Percutaneous Endovascular Thoracic Aneurysm Repair (PTEVAR) or Transcatheter Aortic Valve Implantation (TAVI) in who percutaneous access closure device is used for implanting devices at aorta level.

Primary Outcome Measures

Name	Time	Method
Rate of closure-procedure technical success as assessed by absence of femoral pseudoaneurysm or arterial occlusion	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)	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	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).

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain assessed by the Visual Analog Scale for Pain	30 days	Evaluation of the discomfort or pain after the procedure determined at the end of the procedure with the Visual Analog Scale for Pain, which is a psychometric measuring instrument designed to assess the pain intensity experienced by each patient individually.; The analogous visual scale used for this study measures from 0-10 the intensity of the pain with a series of "faces" that show the intensity in the pain experimentation with categories like "No pain" approximately 0-1, mild, annoying in number 2, nagging in number 4, distressing in number 6, intense in number 8 and worst possible in number 10.
Time of closure procedure hemostasis in seconds	1 hour	Duration in seconds of the arterial closure procedure until complete hemostasis
Hospital Stay assessed in days	30 days	Duration in days until hospital discharge