ClinicalTrials.gg
CompletedNCT07742254ReiCoUpdated Nov 6, 2026

Evaluation of the iCover Stent as a Bridging Stent in Fenestrated Endovascular Aneurysm Repair (fEVAR) for Complex Aortic Aneurysms.

An observational study in Aortic Aneurysm and Aortic Aneurysm Abdominal, sponsored by iVascular S.L.U.. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Primary conditionAortic Aneurysm, AbdominalRegistry: Aortic AneurysmReclassifiedWhy we changed it
Registry
Aortic Aneurysm — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aortic Aneurysm, Abdominal
Why
  1. The study's listed conditions name Aortic Aneurysm, Abdominal, a narrower term within Aortic Aneurysm.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by iVascular S.L.U. · Observational

Updated Nov 6, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
154
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 59 studies in Aortic Aneurysm, Abdominal with a site in France — 10 open to participants now, 13 under way, none of them phase 3. Aortic Aneurysm, Abdominal · France.

Enrollment
23rd of 33
154 · median 181
Started
2026
with 1 other
Observational
33 of 59
4 open now
Registered
59th of 59
by date
Lead sponsor
2 of 59
iVascular S.L.U.

Among the 59 studies in Aortic Aneurysm, Abdominal with a site in France, this one is the 23rd largest by enrollment of the 33 observational ones that give a count, is one of 2 that started in 2026, is one of 33 observational ones, and was the 59th registered.

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

Browse Aortic Aneurysm, Abdominal studies →

Open to participants now

10 of the 59 studies in Aortic Aneurysm, Abdominal with a site in France are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 66 Aortic Aneurysm, Abdominal studies recruiting now, 52 (79%) set no upper age limit and 3 (5%) stop at 75 or younger; 2 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 59 studies in Aortic Aneurysm, Abdominal with a site in France, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Aortic Aneurysm
  • Aortic Aneurysm Abdominal

Browse trials for

Keywords

  • endovascular aneurysm repair
  • fEVAR
  • Bridging stent graft
04

In context

Aortic Aneurysm, Abdominal Reclassified

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's enrollment of 154 is close to the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

iVascular S.L.U. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Compared within Aortic Aneurysm, Abdominal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aortic Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Selection at the primary care clinic

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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. 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 for anti- therapy
  • Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

06

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
154 participants (actual)
Patient registry
No
07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: Periprocedural

  2. Patency

    iCover bridging stent patency post-procedure and at 6-months follow-up (if available retrospectively).

    Time frame: From Day 1 to ≤3 months after the index procedure, and at 6 months follow-up

  3. Endoleaks

    Freedom from iCover bridging stent related endoleaks post-procedure, at 6- (if available retrospectively), and 12- months follow-up

    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)

08

Study locations

3 sites
  • CHU de Bordeaux, Chirurgie Vasculaire et Endovasculaire, Hôpital Pellegrin
    Bordeaux, 33076, France
  • CHU Cavale Blanche, clinique en Cardiologie
    Brest, 29609, France
  • ARTER
    Marseille, 13007, France
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Mar 2026 to primary completion in Jul 2026, 4 months.

Completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Nov 6, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Jul 1, 2026
First posted
Aug 3, 2026
StartActual
Mar 6, 2026
Primary completionActual
Jul 31, 2026
CompletionActual
Sep 30, 2026was Aug 2026
Last update
Nov 6, 2026
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.
Status
Enrolling by invitation→Completed
changed Nov 6, 2026
Study completion
Aug 30, 2026→Sep 30, 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Enrolling by invitation→Completed
    Study completion Aug 30, 2026→Sep 30, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07742254
Lead sponsor
iVascular S.L.U.
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Mar 6, 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026
Last update
Nov 6, 2026

Study contacts

Sara Pich, phD
study director · iVascular

Oversight

Data monitoring committee
No
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 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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