Clinical trial NCT04598802: COvera in BRAnch Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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


Eligibility criteria: 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.

Primary outcomes:
measure: technical success
timeFrame: 30 days
measure: Branch instability
timeFrame: 30 days
measure: Primary clinical success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart & Vascular Center
city: Munich
country: Germany
facility: Ludwig-Maximilians University Hospital
city: Asti
country: Italy
facility: Ospedale di Asti
city: Avellino
country: Italy
facility: Ospedale Giuseppe Moscati
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Cosenza
country: Italy
facility: Azienda Ospedaliera di Cosenza
city: Cuneo
country: Italy
facility: Azienda Ospedaliera Santa Croce e Carle
city: Firenze
country: Italy
facility: Ospedale civile San Giovanni di Dio
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Milan
country: Italy
facility: Ospedale Niguarda
city: Modena
country: Italy
facility: Azienda Ospedaliera di Modena
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Ospedale Civico
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria di Parma
city: Peschiera Del Garda
country: Italy
facility: Ospedale Pederzoli
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Ospedale San Camillo
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Roma
country: Italy
facility: Ospedale San Giovanni Addolorata Britannico
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Roma
country: Italy
facility: Policlinico Umberto I
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Ospedale Molinette
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Treviso
country: Italy
facility: Ospedale Santa Maria di Ca' Foncello di Treviso
city: Trieste
country: Italy
facility: Ospedale di Cattinara
city: Verona
country: Italy
facility: Azienda Ospedaliera di Verona
city: Verona
country: Italy
facility: Ospedale Borgo Roma
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
Study officials:
References:
citation: 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.
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.
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.
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.
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.
citation: 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.