ClinicalTrials.gg
Sign In
CompletedNCT04598802Updated Nov 14, 2022

COvera in BRAnch Registry

An observational study in Aneurysm, sponsored by IRCCS San Raffaele. Completed at 33 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Aneurysm

Browse trials for

03

In context

Aneurysm

956 studies on the registry are indexed under Aneurysm; 171 are open to participants now.

This study's enrollment of 300 is above the median of 150 across 441 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 450 studies on the registry; 234 are open to participants now.

Browse IRCCS San Raffaele studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Covera Plus

    Device: covered stent

Interventions

  • Devicecovered stent

    atherosclerotic aorto-iliac aneurysm

06

What researchers measure

Primary outcomes

  1. technical success

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

    Time frame: 30 days

  2. Branch instability

    freedom from branch-related complications

    Time frame: 30 days

  3. 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

    Time frame: 30 days

07

Study locations

33 sites
  • University Heart & Vascular Center
    Hamburg, Germany
  • Ludwig-Maximilians University Hospital
    Munich, Germany
  • 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
    Florence, Italy
  • Ospedale Policlinico San Martino
    Genova, Italy
  • Azienda Ospedaliera Universitaria Gaetano Martino
    Messina, Italy
  • IRCCS San Raffaele
    Milan, 20132, Italy
  • Ospedale Niguarda
    Milan, Italy
  • Azienda Ospedaliera di Modena
    Modena, Italy
  • Ospedale Cardarelli
    Naples, 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, Italy
08

References and documents

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. PubMed 32081482 ↗
  • 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. PubMed 31882309 ↗
  • 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. PubMed 25176618 ↗
  • 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. PubMed 31882315 ↗
  • 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. PubMed 32173192 ↗
  • 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. PubMed 31901362 ↗
  • 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. PubMed 36822256 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Oct 2022, 24 months.

Of 145 non-industry observational studies under Aneurysm, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's 24 months is below that.

Counting every sponsor, half of 199 studies reached it within 45 months; a quarter within 28 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2020
First posted
Oct 22, 2020
StartActual
Oct 16, 2020
Primary completionActual
Oct 30, 2022
CompletionActual
Oct 30, 2022
Last update
Nov 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04598802
Lead sponsor
IRCCS San Raffaele
Responsible party
Bertoglio Luca (Principal Investigator, IRCCS San Raffaele) — Principal investigator
First posted
Oct 22, 2020
Start date
Oct 16, 2020
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Nov 14, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aneurysm →

Other studies from this sponsor

IRCCS San Raffaele →

Start the discussion