AneurysmNCT04598802
COvera in BRAnch Registry
An observational study of Aneurysm, run by IRCCS San Raffaele at 33 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- What is being tested?
- covered stent
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 16 Oct 2020to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
Italy31 sites
Ospedale di Asti
Asti
Ospedale Giuseppe Moscati
Avellino
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari
Fondazione Poliambulanza
Brescia
Azienda Ospedaliera di Cosenza
Cosenza
Azienda Ospedaliera Santa Croce e Carle
Cuneo
Ospedale civile San Giovanni di Dio
Florence
Ospedale Policlinico San Martino
Genova
Azienda Ospedaliera Universitaria Gaetano Martino
Messina
IRCCS San Raffaele
Milan, 20132
Ospedale Niguarda
Milan
Azienda Ospedaliera di Modena
Modena
Ospedale Cardarelli
Naples
Azienda Ospedaliera di Padova
Padova
Ospedale Civico
Palermo
Azienda Ospedaliera Universitaria di Parma
Parma
Ospedale Pederzoli
Peschiera del Garda
Arcispedale Santa Maria Nuova
Reggio Emilia
Ospedale San Camillo
Roma
Ospedale San Filippo Neri
Roma
Ospedale San Giovanni Addolorata Britannico
Roma
Policlinico Gemelli
Roma
Policlinico Umberto I
Roma
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ospedale Molinette
Torino
Ospedale Santa Chiara
Trento
Ospedale Santa Maria di Ca' Foncello di Treviso
Treviso
Ospedale di Cattinara
Trieste
Azienda Ospedaliera di Verona
Verona
Ospedale Borgo Roma
Verona
Ospedale San Bortolo di Vicenza
Vicenza
Germany2 sites
University Heart & Vascular Center
Hamburg
Ludwig-Maximilians University Hospital
Munich
About this study
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
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
- Conditions
- Aneurysm
- Being tested
- covered stent
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covered stentDevice
atherosclerotic aorto-iliac aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Covera Plus | Not described Receives: Device: covered stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success
freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Measured: 30 days
Branch instability
freedom from branch-related complications
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Oct 2020
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertoglio Luca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598802
- Sponsor's protocol ID
- COBRA Registry
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32081482Tenorio 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 31882309Oikonomou 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 25176618Verzini 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 31882315Zhang 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 32173192Giosdekos 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 31901362Bertoglio 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04598802
- Acronym / sponsor ID
- COBRA Registry
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covera Plus | – | Device: covered stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| covered stentatherosclerotic aorto-iliac aneurysm | Device | Covera Plus |
Primary outcome
technical success
Time frame: 30 days
freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking
Branch instability
Time frame: 30 days
freedom from branch-related complications
Primary clinical success
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 32081482Mirza 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.
- Background: PubMed 31882309Tenorio 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.
- Background: PubMed 25176618Oikonomou 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.
- Background: PubMed 31882315Verzini 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.
- Background: PubMed 32173192Zhang 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.
- Background: PubMed 31901362Giosdekos 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.
- Derived from this study: PubMed 36822256Bertoglio 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by IRCCS San Raffaele at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04598802, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.