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

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

Study Overview

• Status: Completed
• Conditions: Aneurysm
• Intervention / Treatment: Device: covered stent

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • University Heart & Vascular Center
  • Munich, Germany
    • Ludwig-Maximilians University Hospital
• Italy
  • Asti, Italy
    • Ospedale di Asti
  • Avellino, Italy
    • Ospedale Giuseppe Moscati
  • Bari, Italy
    • Azienda Ospedaliero Universitaria Consorziale Policlinico
  • Brescia, Italy
    • Fondazione Poliambulanza
  • Cosenza, Italy
    • Azienda Ospedaliera di Cosenza
  • Cuneo, Italy
    • Azienda Ospedaliera Santa Croce e Carle
  • Firenze, Italy
    • Ospedale Civile San Giovanni di Dio
  • Genova, Italy
    • Ospedale Policlinico San Martino
  • Messina, Italy
    • Azienda Ospedaliera Universitaria Gaetano Martino
  • Milan, Italy, 20132
    • IRCCS San Raffaele
  • Milan, Italy
    • Ospedale Niguarda
  • Modena, Italy
    • Azienda Ospedaliera di Modena
  • Napoli, Italy
    • Ospedale Cardarelli
  • Padova, Italy
    • Azienda Ospedaliera di Padova
  • Palermo, Italy
    • Ospedale Civico
  • Parma, Italy
    • Azienda Ospedaliera Universitaria di Parma
  • Peschiera Del Garda, Italy
    • Ospedale Pederzoli
  • Reggio Emilia, Italy
    • Arcispedale Santa Maria Nuova
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy
    • Ospedale San Filippo Neri
  • Roma, Italy
    • Policlinico Gemelli
  • Roma, Italy
    • Ospedale San Camillo
  • Roma, Italy
    • Ospedale San Giovanni Addolorata Britannico
  • San Giovanni Rotondo, Italy
    • Ospedale Casa Sollievo della Sofferenza
  • Torino, Italy
    • Ospedale Molinette
  • Trento, Italy
    • Ospedale Santa Chiara
  • Treviso, Italy
    • Ospedale Santa Maria di Ca' Foncello di Treviso
  • Trieste, Italy
    • Ospedale di Cattinara
  • Verona, Italy
    • Azienda Ospedaliera di Verona
  • Verona, Italy
    • Ospedale Borgo Roma
  • Vicenza, Italy
    • Ospedale San Bortolo di Vicenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covera Plus	Device: covered stent; atherosclerotic aorto-iliac aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• 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.
• Tenorio 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.
• Oikonomou 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.
• Verzini 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.
• Zhang 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.
• Giosdekos 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2020
• Primary Completion (ACTUAL): October 30, 2022
• Study Completion (ACTUAL): October 30, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: COBRA Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No