Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

Sociedad Espanola de Angiologia y Cirugia Vascular

Status: Unknown

Conditions: Aorta Stenosis; Aortic Valve Stenosis; Aorta Aneurysm; Aortic Valve Disease; Aortic Rupture; Aortic Coarctation; Aorta Dissection

Treatments: Device: Perclose Proglide (Abbott)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04307888

RIV-2019-01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Study group

Description:

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.

Treatment:

Device: Perclose Proglide (Abbott)