COvera in BRAnch Registry

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

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Key information

Conditions

Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart & Vascular Center, Hamburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

covered stent

Device

atherosclerotic aorto-iliac aneurysm

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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 22, 2020
Registry last updated: Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed