Aortic AneurysmReiCoNCT07742254
Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
An observational study of Aortic Aneurysm and Aortic Aneurysm Abdominal, run by iVascular S.L.U. at 3 sites in France.
Trial summary
ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR for complex abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Aneurysm Abdominal
- How many people
- 154 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Mar 2026to 30 Sep 2026
- 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: Selection at the primary care clinic
Who may be able to join
- Underwent a fEVAR procedure between 05/2021 and 12/2024 at one of the participating sites.
- Received at least one iCover stent graft (iVascular, Barcelona, Spain) as a bridging stent during the fEVAR procedure.
- The iCover stent was used to bridge a fenestration in the renal or visceral arteries.
- At least one target vessel is connected with one iCover bridging stent graft (BSG) as standard configuration; use of a second iCover for the same target vessel is acceptable only if relining was required during the procedure
- Only commercially available endografts were used during the fEVAR procedure (excluding physician-modified devices).
- Sites must have a standardized follow-up protocol, ensuring consistent imaging and reporting practices.
- It is recommended to include subjects with follow-up CTA and/or DUS imaging data available for iCover as BSG for a minimum of 1 year from the date of treatment/procedure or until time of death, whichever came first.
- Patients for whom existing medical data are available and who have been informed about the retrospective study via an information letter, without having expressed any objection to the use of their data.
Who cannot join
- Subjects with ages 18 or below at the time of the procedure.
- Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- Target vessel was previously stented prior to iCover implantation.
- Target vessels with severe (>50%) pre-stent stenosis or occlusion on preoperative imaging where assessment of iCover stent performance was not possible due to lack of adequate post-deployment imaging.
- Patients with incomplete data for the in-hospital phase (eg. GFR rate, intraoperative blood loss, fluroscopy time).
- Target vessels less than 5 mm in diameter and/or severe vascular diseases (heavy calcification or occlusion, that may compromise device deployment, imaging accuracy or follow up assessment) as assessed by the treating physician.
- Patients contraindicated for anti-platelet therapy
- Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin
Bordeaux, 33076
CHU Cavale Blanche, clinique en Cardiologie
Brest, 29609
ARTER
Marseille, 13007
About this study
ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR for complex abdominal aortic aneurysms. The aim is to demonstrate conformity by collecting clinical evidence supporting the safe and effective use of this device in fEVAR procedures.
Read the detailed description
This retrospective clinical study evaluates the safety and performance of the iCover stent graft when used as a bridging stent in fenestrated endovascular aortic repair (fEVAR) for complex aortic aneurysms.
In fEVAR procedures, bridging stents are essential for connecting fenestrations in the aortic endograft to visceral target vessels, maintaining visceral perfusion and ensuring aneurysmal sac exclusion preventing risk of rupture and death.
The study aims to gather real-world data on iCover's clinical outcomes in this routine application, potentially supporting future conformity assessment for its extended use in fEVAR. Early studies suggest that iCover has a strong technical success, durability, and target vessel stability when repurposed as a bridging stent.
Up to date, three physician-initiated studies have assessed iCover´s performance as a bridging stent in fEVAR procedures, providing important early evidence of its performance and safety. Although 4 dedicated and approved devices for this indication have become available in the past year, variability in anatomical and procedural requirements continues to drive the evaluation of alternative technologies. This study aims to contribute important safety and performance data to inform future clinical and regulatory considerations for the iCover device in this specific indication.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal
- Keywords
- endovascular aneurysm repair, fEVAR, Bridging stent graft
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary performance endpoint; Primary safety endpoint
iCover bridging stent patency at 12 months, defined as the proportion of iCover stents showing an absence of binary restenosis (≥ 50% stenosis) based on computed tomography angiography (CTA) and/or duplex ultrasound (DUS).
Absence of iCover-related target vessel instability up to 12 months, defined as the rate of patient with an absence of target vessel instability described as a composite endpoint of any branch-related complication leading to: Aneurysm rupture/ death/ occlusion/ component separation/ or reintervention to maintain branch patency or to treat a branch-related component separation or endoleak between implantation and 12 months visit.
Measured: 12 months
Secondary outcomes (3)
Technical success rate
Technical success rate: defined as successful introduction, deployment and appropriate positioning of the iCover bridging stent in all intended target vessels without immediate Type I or III endoleaks or conversion to open repair.
Measured: Periprocedural
Patency
iCover bridging stent patency post-procedure and at 6-months follow-up (if available retrospectively).
Measured: From Day 1 to ≤3 months after the index procedure, and at 6 months follow-up
Endoleaks
Freedom from iCover bridging stent related endoleaks post-procedure, at 6- (if available retrospectively), and 12- months follow-up
Measured: From Day 1 to ≤3 months after the index procedure, at 6- (if available retrospectively, >3 to ≤9 months), and 12- months follow-up (>9 to ≤18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start6 Mar 2026
- Primary completion31 Jul 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Pich, phD, Study director, iVascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742254
- Sponsor's protocol ID
- RO-20250710
- Other IDs
- N° 27753917
- Acronym
- ReiCo
- Status last verified
- Nov 2026
- First submitted
- 1 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT07742254
- Acronym / sponsor ID
- ReiCo / RO-20250710
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal
- Keywords
- endovascular aneurysm repair, fEVAR, Bridging stent graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 3 Aug 2026 (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.
ReiCo is a French retrospective, multicenter, single-arm study focused on assessing the safety and clinical performance of the iCover balloon-expandable covered stent (iVascular) when implanted as a bridging stent during fEVAR for complex abdominal aortic aneurysms. The aim is to demonstrate conformity by collecting clinical evidence supporting the safe and effective use of this device in fEVAR procedures.
Detailed description
This retrospective clinical study evaluates the safety and performance of the iCover stent graft when used as a bridging stent in fenestrated endovascular aortic repair (fEVAR) for complex aortic aneurysms.
In fEVAR procedures, bridging stents are essential for connecting fenestrations in the aortic endograft to visceral target vessels, maintaining visceral perfusion and ensuring aneurysmal sac exclusion preventing risk of rupture and death.
The study aims to gather real-world data on iCover's clinical outcomes in this routine application, potentially supporting future conformity assessment for its extended use in fEVAR. Early studies suggest that iCover has a strong technical success, durability, and target vessel stability when repurposed as a bridging stent.
Up to date, three physician-initiated studies have assessed iCover´s performance as a bridging stent in fEVAR procedures, providing important early evidence of its performance and safety. Although 4 dedicated and approved devices for this indication have become available in the past year, variability in anatomical and procedural requirements continues to drive the evaluation of alternative technologies. This study aims to contribute important safety and performance data to inform future clinical and regulatory considerations for the iCover device in this specific indication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Selection at the primary care clinic
Key inclusion criteria (8 listed)
- Underwent a fEVAR procedure between 05/2021 and 12/2024 at one of the participating sites.
- Received at least one iCover stent graft (iVascular, Barcelona, Spain) as a bridging stent during the fEVAR procedure.
- The iCover stent was used to bridge a fenestration in the renal or visceral arteries.
- At least one target vessel is connected with one iCover bridging stent graft (BSG) as standard configuration; use of a second iCover for the same target vessel is acceptable only if relining was required during the procedure
- Only commercially available endografts were used during the fEVAR procedure (excluding physician-modified devices).
Key exclusion criteria (8 listed)
- Subjects with ages 18 or below at the time of the procedure.
- Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- Target vessel was previously stented prior to iCover implantation.
- Target vessels with severe (>50%) pre-stent stenosis or occlusion on preoperative imaging where assessment of iCover stent performance was not possible due to lack of adequate post-deployment imaging.
- Patients with incomplete data for the in-hospital phase (eg. GFR rate, intraoperative blood loss, fluroscopy time).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary performance endpoint; Primary safety endpoint
Time frame: 12 months
iCover bridging stent patency at 12 months, defined as the proportion of iCover stents showing an absence of binary restenosis (≥ 50% stenosis) based on computed tomography angiography (CTA) and/or duplex ultrasound (DUS). Absence of iCover-related target vessel instability up to 12 months, defined as the rate of patient with an absence of target vessel instability described as a composite endpoint of any branch-related complication leading to: Aneurysm rupture/ death/ occlusion/ component separation/ or reintervention to maintain branch patency or to treat a branch-related component separation or endoleak between implantation and 12 months visit.
3 secondary outcomes
Technical success rate
Time frame: Periprocedural
Patency
Time frame: From Day 1 to ≤3 months after the index procedure, and at 6 months follow-up
Endoleaks
Time frame: From Day 1 to ≤3 months after the index procedure, at 6- (if available retrospectively, >3 to ≤9 months), and 12- months follow-up (>9 to ≤18 months)
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Sara Pich, phD study director
iVascular
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortic Aneurysm Abdominal, run by iVascular S.L.U. at 3 sites in France.
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 8 inclusion and 8 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Primary performance endpoint; Primary safety endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.