NCT04307888

Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Sociedad Espanola de Angiologia y Cirugia Vascular · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aorta Aneurysm
• Aorta Dissection
• Aorta Stenosis
• Aortic Coarctation
• Aortic Rupture
• Aortic Valve Disease
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Perclose Proglide (Abbott)	Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-03-01
• Completion: 2022-03-01
• First posted: 2020-03-13
• Last updated: 2020-03-23

Regulatory

• FDA-regulated device study