NCT04598802
Completed
N/A
A Physician-initiated, Multicentre, Ambispective, Observational Registry of Patients Undergoing Complex Aortic Procedures With the Use of the Bard Covera Plus (Tempe, Arizona, USA) Covered Self-expandable Stents
ConditionsAneurysm
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aneurysm
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 300
- Locations
- 33
- Primary Endpoint
- technical success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a multibranched endograft
Investigators
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele
Eligibility Criteria
Inclusion Criteria
- •Adult patients ≥18 years
- •Patients who underwent/will undergo a complex aortic procedure with the use of a Covera Plus covered stent graft as a bridging stent, in the centres involved in this Registry
- •Subject has consented for study participation and signed the approved Informed Consent
Exclusion Criteria
- •Bleeding diathesis or coagulopathy
- •Patients with active systemic or cutaneous infection or inflammation
- •Patients who are pregnant or lactating
- •Patient younger than 18 years of age
- •Patients who did not receive treatment using a Covera Plus covered stent graft.
Outcomes
Primary Outcomes
technical success
Time Frame: 30 days
freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Branch instability
Time Frame: 30 days
freedom from branch-related complications
Primary clinical success
Time Frame: 30 days
freedom from death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoraco-abdominal pathologies
Study Sites (33)
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