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Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY)

NCT04307888 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2020-03-23

No results posted yet for this study

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

DEVICE

Perclose Proglide (Abbott)

Common Femoral Artery percutaneous access closure by means of Perclose Proglide device

Sponsors & Collaborators

  • Sociedad Espanola de Angiologia y Cirugia Vascular

    lead NETWORK

Principal Investigators

  • Teresa Hernandez Carbonell, MD · Hospital Quiron Salud Marbella

  • Francisco J Medina, MD · Hospital Universitario Burgos

  • Ignacio Agundez-Gomez, MD · Hospital Universitario Burgos

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-03-31
Completion
2022-03-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307888 on ClinicalTrials.gov