COvera in BRAnch Registry

Completed

• Conditions: Aneurysm
• Interventions: Device: covered stent

• Registration Number: NCT04598802
• Lead Sponsor: IRCCS San Raffaele

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-16
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-22
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covera Plus	covered stent	-

Primary Outcome Measures

Name	Time	Method
technical success	30 days	freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Branch instability	30 days	freedom from branch-related complications
Primary clinical success	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

Trial Locations

Locations (33)

Azienda Ospedaliera di Verona; 🇮🇹 Verona, Italy

Ospedale San Giovanni Addolorata Britannico; 🇮🇹 Roma, Italy

Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy

Ospedale San Filippo Neri; 🇮🇹 Roma, Italy

Policlinico Umberto I; 🇮🇹 Roma, Italy

Ospedale Santa Chiara; 🇮🇹 Trento, Italy

Ospedale San Bortolo di Vicenza; 🇮🇹 Vicenza, Italy

University Heart & Vascular Center; 🇩🇪 Hamburg, Germany

Ludwig-Maximilians University Hospital; 🇩🇪 Munich, Germany

Ospedale Giuseppe Moscati; 🇮🇹 Avellino, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico; 🇮🇹 Bari, Italy

Azienda Ospedaliera di Cosenza; 🇮🇹 Cosenza, Italy

Ospedale Niguarda; 🇮🇹 Milan, Italy

Ospedale Civico; 🇮🇹 Palermo, Italy

Ospedale di Asti; 🇮🇹 Asti, Italy

Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

Azienda Ospedaliera Santa Croce e Carle; 🇮🇹 Cuneo, Italy

Ospedale civile San Giovanni di Dio; 🇮🇹 Firenze, Italy

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Azienda Ospedaliera Universitaria Gaetano Martino; 🇮🇹 Messina, Italy

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Azienda Ospedaliera di Modena; 🇮🇹 Modena, Italy

Ospedale Cardarelli; 🇮🇹 Napoli, Italy

Ospedale San Camillo; 🇮🇹 Roma, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera Universitaria di Parma; 🇮🇹 Parma, Italy

Ospedale Pederzoli; 🇮🇹 Peschiera Del Garda, Italy

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Policlinico Gemelli; 🇮🇹 Roma, Italy

Ospedale Santa Maria di Ca' Foncello di Treviso; 🇮🇹 Treviso, Italy

Ospedale di Cattinara; 🇮🇹 Trieste, Italy

Ospedale Borgo Roma; 🇮🇹 Verona, Italy