Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New stent could improve safety in aortic aneurysm surgery

NCT ID NCT07529275

Disease control Sponsor: iVascular S.L.U. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new type of stent called iCover, used during a procedure to repair complex abdominal aortic aneurysms. The stent helps keep blood flowing to vital organs. Researchers will check if the stent stays open and prevents complications over one year. About 165 people will take part across multiple European centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iCover balloon-expandable covered stent (a mesh tube used to keep arteries open)
What this could lead to
If successful, this stent could offer a safer, more durable option for repairing complex aortic aneurysms, reducing the need for repeat procedures.
What could go wrong
This is an early-stage study with only 165 participants, so results may not apply to everyone. Stents can fail over time, and there are risks like blockage or rupture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient suitable for treatment of a juxta, para-renal, suprarenal or thoracoabdominal aneurysm with a fenestrated endoprosthesis in accordance with current indications and guidelines for the management of abdominal aortic aneurysms (aneurysm \> 5 centimetres for women and \> 5.5 centimetres for men and/or growth \> 5 mm in 6 months or 1 centimetre in 1 year). 2. The fenestrated endograft must be designed in a way that positions the fenestrations directly in front of the orifice of the target vessel, ensuring that the distance between the fenestration and the orifice of the target vessel does not exceed 5 mm. 3. Anatomy and patient strictly in accordance with the Instructions For Use (IFU) of the fenestrated endograft chosen to be implanted: 1. Cook Medical: Zenith Fenestrated AAA Endovascular Graft 2. Terumo Aortic: TREO and Anaconda Fenestrated Stent Grafts 3. JOTEC (part of Artivion): E-xtra design engineering. 4. Additional iCover stent, if necessary, could be placed in the same target artery (2 iCovers stents max as bridging stent for each fenestration). 5. Landing zone in the target vessel of at least 10 mm. 6. Target arteries (renal arteries, superior mesenteric artery, celiac trunk) with a diameter between 5 and 10 mm. 7. Angulation of the aorta at the level of the target vessels \< 45 degrees. 8. No early significant branching from the target vessel with a potential risk of coverage and subsequent significant risk of target organ infarctions. 9. Age \> 55 years. 10. Patient having notified his consent to this study and willing to comply with specified follow-up evaluations at the specified times. 11. Patient affiliated to or benefiting from a social security system. 12. Patient with life expectancy \> 12 months. Exclusion Criteria: 1. Patients contraindicated for anti-platelet therapy. 2. Patients with uncontrolled haematological disorders or heparin-induced thrombocytopenia. 3. Chronic or acute aortic dissection. 4. Patients refusing treatment. 5. Patients who are pregnant or wish to become pregnant. 6. Patients scheduled for major or life-saving surgery within 30 days of the fenestrated stent procedure. 7. Patients considered hemodynamically unstable or requiring emergency treatment. 8. Patients with severe arteriopathy leading to adverse outflow, which may impair bridging stent patency on the targeted artery. 9. Thrombus in the aortic sealing zone and target arteries with thickness \> to 3 mm. 10. Stenosis (\>50%) or occlusion of target arteries or distal disease resulting in poor iCover stent outflow. 11. Patients allergic to stent materials (L605) and/or PTFE. 12. Patients requiring a hybrid aortic technique with branches, semibranches or chimneys. 13. Patient who has been implanted with any stent type or brand other than iCover as a bridging stent in any target artery. 14. Patients with infectious/mycotic aneurysms. 15. Angulation between renal artery and aortic wall \< 30 degrees. 16. Patients with complex iliac accesses out the IFUs of the fenestrated endograft chosen to be implanted (COOK Medical / Terumo Aortic/Jotec-Artivion) with the iCover Bridging stent. 17. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period that may interfere with the results of this study. 18. Myocardial infarction or stroke within 3 months prior to the procedure. 19. Patients with an unstable angina pectoris or heart insufficiency NYHA 3 or 4. 20. Patients with ASA classification 5 or higher. 21. Patients with physician modified endografts or in situ laser FEVAR.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Complex abdominal aortic aneurysms are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex abdominal aortic aneurysms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM- Hôpital De La Timone

    NOT_YET_RECRUITING

    Marseille, 13005, France

    Contact Email: •••••@•••••

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, 1105, Netherlands

    Contact Email: •••••@•••••

  • Asklepios Klinik St. Georg

    NOT_YET_RECRUITING

    Hamburg, 20099, Germany

    Contact Email: •••••@•••••

  • CHU BORDEAUX-Hopital Tripode

    RECRUITING

    Bordeaux, 33076, France

    Contact Email: •••••@•••••

  • CHU BREST- la Cavale Blanche

    NOT_YET_RECRUITING

    Brest, 29200, France

    Contact Email: •••••@•••••

  • CHU LILLE- Institut Cœur Poumon

    NOT_YET_RECRUITING

    Lille, 59000, France

    Contact Email: •••••@•••••

  • CHU TOULOUSE- Hôpital Rangueil

    NOT_YET_RECRUITING

    Toulouse, 31400, France

    Contact Email: •••••@•••••

  • Chu Liege

    NOT_YET_RECRUITING

    Liège, B-4000, Belgium

    Contact Email: •••••@•••••

  • Grand hopital Saint Josep

    NOT_YET_RECRUITING

    Gilly, 6060, Belgium

    Contact Email: •••••@•••••

  • Hospital Clinic - University of Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

    Contact Email: •••••@•••••

  • Hôpital St Joseph

    NOT_YET_RECRUITING

    Marseille, 13008, France

    Contact Email: •••••@•••••

  • Hôpital privé de Villeneuve d'Ascq

    NOT_YET_RECRUITING

    Villeneuve-d'Ascq, 59650, France

    Contact Email: •••••@•••••

  • Imelda Ziekenhuis

    NOT_YET_RECRUITING

    Bonheiden, 2820, Belgium

    Contact Email: •••••@•••••

  • Jessa Hasselt

    NOT_YET_RECRUITING

    Hasselt, 3800, Belgium

    Contact Email: •••••@•••••

  • LMU München Campus Großhadern

    NOT_YET_RECRUITING

    München, 81377, Germany

    Contact Email: •••••@•••••

  • Maria Middelares GENT

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

    Contact Email: •••••@•••••

  • Nouvel Hôpital Privé les Franciscaines

    NOT_YET_RECRUITING

    Nîmes, 30000, France

    Contact Email: •••••@•••••

  • TUM Munich

    NOT_YET_RECRUITING

    München, 81675, Germany

    Contact Email: •••••@•••••

  • UZ GENT

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

    Contact Email: •••••@•••••

  • Uni-Klinikum Leipzig

    NOT_YET_RECRUITING

    Leipzig, 04103, Germany

    Contact Email: •••••@•••••

  • University Hospital Cologne

    NOT_YET_RECRUITING

    Cologne, 50937, Germany

    Contact Email: •••••@•••••

  • University Medical Center Groningen

    NOT_YET_RECRUITING

    Groningen, 9700, Netherlands

    Contact Email: •••••@•••••

  • Universitätsklinik Hamburg Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

    Contact Email: •••••@•••••

  • ZOL GENK

    NOT_YET_RECRUITING

    Genk, 3600, Belgium

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.