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
1 other identifier
observational
300
2 countries
33
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedStudy Start
First participant enrolled
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedNovember 14, 2022
November 1, 2022
2 years
October 16, 2020
November 10, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
technical success
freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
30 days
Branch instability
freedom from branch-related complications
30 days
Primary clinical success
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
30 days
Study Arms (1)
Covera Plus
Interventions
Eligibility Criteria
300 patients treated from January 2018 to January 2022 for atherosclerotic aorto-iliac aneurysm with procedures requiring the use of the Covera Plus covered stent in combination with a branched endograft
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University Heart & Vascular Center
Hamburg, Germany
Ludwig-Maximilians University Hospital
Munich, Germany
Ospedale di Asti
Asti, Italy
Ospedale Giuseppe Moscati
Avellino, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
Fondazione Poliambulanza
Brescia, Italy
Azienda Ospedaliera di Cosenza
Cosenza, Italy
Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy
Ospedale civile San Giovanni di Dio
Florence, Italy
Ospedale Policlinico San Martino
Genova, Italy
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, Italy
IRCCS San Raffaele
Milan, 20132, Italy
Ospedale Niguarda
Milan, Italy
Azienda Ospedaliera di Modena
Modena, Italy
Ospedale Cardarelli
Napoli, Italy
Azienda Ospedaliera di Padova
Padua, Italy
Ospedale Civico
Palermo, Italy
Azienda Ospedaliera Universitaria di Parma
Parma, Italy
Ospedale Pederzoli
Peschiera del Garda, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Ospedale San Camillo
Roma, Italy
Ospedale San Filippo Neri
Roma, Italy
Ospedale San Giovanni Addolorata Britannico
Roma, Italy
Policlinico Gemelli
Roma, Italy
Policlinico Umberto I
Roma, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Ospedale Molinette
Torino, Italy
Ospedale Santa Chiara
Trento, Italy
Ospedale Santa Maria di Ca' Foncello di Treviso
Treviso, Italy
Ospedale di Cattinara
Trieste, Italy
Azienda Ospedaliera di Verona
Verona, Italy
Ospedale Borgo Roma
Verona, Italy
Ospedale San Bortolo di Vicenza
Vicenza, Italy
Related Publications (7)
Mirza AK, Tenorio ER, Karkkainen JM, Hofer J, Macedo T, Cha S, Ozbek P, Oderich GS. Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms. J Vasc Surg. 2020 Aug;72(2):423-434.e1. doi: 10.1016/j.jvs.2019.09.046. Epub 2020 Feb 17.
PMID: 32081482BACKGROUNDTenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts. J Vasc Surg. 2020 Sep;72(3):822-836.e9. doi: 10.1016/j.jvs.2019.10.091. Epub 2019 Dec 25.
PMID: 31882309BACKGROUNDOikonomou K, Kopp R, Katsargyris A, Pfister K, Verhoeven EL, Kasprzak P. Outcomes of fenestrated/branched endografting in post-dissection thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):641-8. doi: 10.1016/j.ejvs.2014.07.005. Epub 2014 Aug 28.
PMID: 25176618BACKGROUNDVerzini F, Parlani G, Varetto G, Gibello L, Boero M, Torsello GF, Donas KP, Simonte G; pELVIS Investigators. Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry. J Vasc Surg. 2020 Aug;72(2):549-555.e1. doi: 10.1016/j.jvs.2019.09.065. Epub 2019 Dec 25.
PMID: 31882315BACKGROUNDZhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.
PMID: 32173192BACKGROUNDGiosdekos A, Antonopoulos CN, Sfyroeras GS, Moulakakis KG, Tsilimparis N, Kakisis JD, Lazaris A, Chatziioannou A, Geroulakos G. The use of iliac branch devices for preservation of flow in internal iliac artery during endovascular aortic aneurysm repair. J Vasc Surg. 2020 Jun;71(6):2133-2144. doi: 10.1016/j.jvs.2019.10.087. Epub 2019 Dec 31.
PMID: 31901362BACKGROUNDBertoglio L, Grandi A, Veraldi GF, Pulli R, Antonello M, Bonvini S, Isernia G, Bellosta R, Buia F, Silingardi R; COBRA Registry Collaborators. Midterm results on a new self-expandable covered stent combined with branched stent grafts: Insights from a multicenter Italian registry. J Vasc Surg. 2023 Jun;77(6):1598-1606.e3. doi: 10.1016/j.jvs.2023.02.007. Epub 2023 Feb 22.
PMID: 36822256DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 16, 2020
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
November 14, 2022
Record last verified: 2022-11