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COvera in BRAnch Registry

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04598802
Enrollment
300
Registered
2020-10-22
Start date
2020-10-16
Completion date
2022-10-30
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm

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

Interventions

atherosclerotic aorto-iliac aneurysm

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
technical success30 daysfreedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Branch instability30 daysfreedom from branch-related complications
Primary clinical success30 daysfreedom 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

Countries

Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026