COvera in BRAnch Registry

NCT ID: NCT04598802

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-16

Study Completion Date

2022-10-30

Brief Summary

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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

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Conditions

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Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Covera Plus

covered stent

Intervention Type DEVICE

atherosclerotic aorto-iliac aneurysm

Interventions

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covered stent

atherosclerotic aorto-iliac aneurysm

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Bertoglio Luca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Heart & Vascular Center

Hamburg, , Germany

Site Status

Ludwig-Maximilians University Hospital

Munich, , Germany

Site Status

Ospedale di Asti

Asti, , Italy

Site Status

Ospedale Giuseppe Moscati

Avellino, , Italy

Site Status

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, , Italy

Site Status

Fondazione Poliambulanza

Brescia, , Italy

Site Status

Azienda Ospedaliera di Cosenza

Cosenza, , Italy

Site Status

Azienda Ospedaliera Santa Croce e Carle

Cuneo, , Italy

Site Status

Ospedale civile San Giovanni di Dio

Florence, , Italy

Site Status

Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, , Italy

Site Status

IRCCS San Raffaele

Milan, , Italy

Site Status

Ospedale Niguarda

Milan, , Italy

Site Status

Azienda Ospedaliera di Modena

Modena, , Italy

Site Status

Ospedale Cardarelli

Napoli, , Italy

Site Status

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

Ospedale Civico

Palermo, , Italy

Site Status

Azienda Ospedaliera Universitaria di Parma

Parma, , Italy

Site Status

Ospedale Pederzoli

Peschiera del Garda, , Italy

Site Status

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Ospedale San Camillo

Roma, , Italy

Site Status

Ospedale San Filippo Neri

Roma, , Italy

Site Status

Ospedale San Giovanni Addolorata Britannico

Roma, , Italy

Site Status

Policlinico Gemelli

Roma, , Italy

Site Status

Policlinico Umberto I

Roma, , Italy

Site Status

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Ospedale Molinette

Torino, , Italy

Site Status

Ospedale Santa Chiara

Trento, , Italy

Site Status

Ospedale Santa Maria di Ca' Foncello di Treviso

Treviso, , Italy

Site Status

Ospedale di Cattinara

Trieste, , Italy

Site Status

Azienda Ospedaliera di Verona

Verona, , Italy

Site Status

Ospedale Borgo Roma

Verona, , Italy

Site Status

Ospedale San Bortolo di Vicenza

Vicenza, , Italy

Site Status

Countries

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Germany Italy

References

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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.

Reference Type BACKGROUND
PMID: 32081482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31882309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25176618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31882315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32173192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31901362 (View on PubMed)

Bertoglio 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.

Reference Type DERIVED
PMID: 36822256 (View on PubMed)

Other Identifiers

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COBRA Registry

Identifier Type: -

Identifier Source: org_study_id

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