COvera in BRAnch Registry

Aneurysm Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598802
• Other study ID #: COBRA Registry
• Status: Completed
• Start date: October 16, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm

Intervention

Device:
• covered stent
atherosclerotic aorto-iliac aneurysm

Locations

Country	Name	City	State
Germany	University Heart & Vascular Center	Hamburg
Germany	Ludwig-Maximilians University Hospital	Munich
Italy	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	Firenze
Italy	Ospedale Policlinico San Martino	Genova
Italy	Azienda Ospedaliera Universitaria Gaetano Martino	Messina
Italy	IRCCS San Raffaele	Milan
Italy	Ospedale Niguarda	Milan
Italy	Azienda Ospedaliera di Modena	Modena
Italy	Ospedale Cardarelli	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (6)

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. — View Citation

Mirza AK, Tenorio ER, Kärkkäinen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	technical success	freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking	30 days
Primary	Branch instability	freedom from branch-related complications	30 days
Primary	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