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COvera in BRAnch Registry

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT04598802
Collaborator
(none)
300
Enrollment
33
Locations
26.4
Anticipated Duration (Months)
9.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: covered stent

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Actual Study Start Date :
Oct 16, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Covera Plus

Device: covered stent
atherosclerotic aorto-iliac aneurysm

Outcome Measures

Primary Outcome Measures

  1. technical success [30 days]

    freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking

  2. Branch instability [30 days]

    freedom from branch-related complications

  3. Primary clinical success [30 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Heart & Vascular Center Hamburg Germany
2 Ludwig-Maximilians University Hospital Munich Germany
3 Ospedale di Asti Asti Italy
4 Ospedale Giuseppe Moscati Avellino Italy
5 Azienda Ospedaliero Universitaria Consorziale Policlinico Bari Italy
6 Fondazione Poliambulanza Brescia Italy
7 Azienda Ospedaliera di Cosenza Cosenza Italy
8 Azienda Ospedaliera Santa Croce e Carle Cuneo Italy
9 Ospedale civile San Giovanni di Dio Firenze Italy
10 Ospedale Policlinico San Martino Genova Italy
11 Azienda Ospedaliera Universitaria Gaetano Martino Messina Italy
12 IRCCS San Raffaele Milan Italy 20132
13 Ospedale Niguarda Milan Italy
14 Azienda Ospedaliera di Modena Modena Italy
15 Ospedale Cardarelli Napoli Italy
16 Azienda Ospedaliera di Padova Padova Italy
17 Ospedale Civico Palermo Italy
18 Azienda Ospedaliera Universitaria di Parma Parma Italy
19 Ospedale Pederzoli Peschiera Del Garda Italy
20 Arcispedale Santa Maria Nuova Reggio Emilia Italy
21 Ospedale San Camillo Roma Italy
22 Ospedale San Filippo Neri Roma Italy
23 Ospedale San Giovanni Addolorata Britannico Roma Italy
24 Policlinico Gemelli Roma Italy
25 Policlinico Umberto I Roma Italy
26 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
27 Ospedale Molinette Torino Italy
28 Ospedale Santa Chiara Trento Italy
29 Ospedale Santa Maria di Ca' Foncello di Treviso Treviso Italy
30 Ospedale di Cattinara Trieste Italy
31 Azienda Ospedaliera di Verona Verona Italy
32 Ospedale Borgo Roma Verona Italy
33 Ospedale San Bortolo di Vicenza Vicenza Italy

Sponsors and Collaborators

  • IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bertoglio Luca, Principal Investigator, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT04598802
Other Study ID Numbers:
  • COBRA Registry
First Posted:
Oct 22, 2020
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aneurysm

Study Results

No Results Posted as of Jul 12, 2022