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Can a new device prevent aortic aneurysm rupture?

NCT ID NCT03024554

Disease control Sponsor: Cardiatis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial is evaluating a new device called the Bifurcated Multilayer Flow Modulator (BMFM) for treating abdominal aortic aneurysms that involve the iliac arteries. The device is designed to be implanted inside the blood vessel to help stabilize the aneurysm and prevent it from rupturing. The study will include adults over 18 with this condition and will track safety and performance over 12 months, focusing on freedom from rupture and aneurysm-related death.

What this could mean

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

Active substance
Bifurcated Multilayer Flow Modulator (BMFM) – a device implanted to treat aortic aneurysms
What this could lead to
If successful, this device could offer a less invasive treatment option for abdominal aortic aneurysms, potentially reducing the risk of rupture and improving patient outcomes.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not be conclusive. Risks include device-related complications, aneurysm rupture, or the device not performing as expected.

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

42 people

The number who actually took part.

Started

Apr 2014

Finished

Dec 2023

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

18 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: Patients must meet ALL of the following criteria: * Age over 18 * Life expectancy \> 12 months * Aortic aneurysms involving iliac arteries * Healthy proximal and distal landing zone * Adequate arterial access * Healthy branches and collaterals (no stenosis or previously treated by angioplasty) * Informed consent understood, signed and patient agrees to all follow-up visits Exclusion Criteria: Patients will be excluded if ANY of the following conditions apply: * Aneurysm rupture, impending or contained rupture * Aortic dissection * Aortic root aneurysm * Pleural effusion * Prior all surgical procedure within 30 days unless procedure is in preparation for device implantation or planned within 30 days post stent deployment * Myocardial infarction or cerebral vascular accident within 6 weeks of treatment * Presence/suspicion of connective tissue disorders, for example, Marfan or Ehlers-Danlos etc. * Contraindications to the anticoagulant or/ and antiplatelet medications * Allergic reaction to a contrast agent * Patient with undergoing or planned chemotherapy * History of bleeding disorder (coagulopathy) or thrombophilia * Shaggy aorta * Takayasu's arteritis * Presence/suspicion of infection (for example: mycotic aorta) * The use of the MFM® with stent-grafts or previously implanted stent-grafts * Pregnant or breastfeeding woman * Patients included in another clinical study

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal

As listed by the trial registrant

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

Aortic aneurysm, abdominal Aortic aneurysm, thoracoabdominal

Contacts and locations

Locations

  • CMC Coeur et Vaisseaux

    Salé, 11150, Morocco

  • City Hospital Clinic

    Sofia, Bulgaria

  • ELYTIS Hospital: Spital Multidisciplinar şi Policlinică

    Iași, 700010, Romania

  • European Hospital Polisano

    Sibiu, 550172, Romania

  • Hôpitaux IRIS Sud Molière Longchamps

    Brussels, Uccle, 1190, Belgium

  • Maribor University Medical Centre

    Maribor, Slovenia

  • University Medical Centre Ljubljana

    Ljubljana, Slovenia

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