Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm

NCT03024554 | Completed Results

• 1 other identifier: 12-2013
• Study Type: interventional
• Target: 42
• Locations: 5 countries
• Sites: 7

Brief Summary

The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries. The BMFM is an adaptation of the aortic MFM® to the aorto-iliac bifurcation anatomy. It should be noted that the aortic MFM® has CE mark approval for the aortic aneurysm treatment.

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal

Keywords

aortic aneurysm involving iliac arteries; abdominal aortic aneurysm; MFM; Multilayer Flow Modulator; Multilayer Stent

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Unruptured Aneurysm

  Number of patients free from aortic aneurysm rupture at the 12-month timepoint

  12 months

• Aneurysm-related Mortality

  Number of patients who had died as a consequence of their aortic aneurysm, at the 30-day, 6-month and 12-month timepoints

  At 30 days, 6 and 12 months

Secondary Outcomes (10)

• Number of Branches and Collaterals Patent

  12 months

• All Cause Mortality

  30 days, 6 months and 12 months

• Number of Patients With Major Adverse Events

  12 months

• Technical Success

  The technical success was evaluated immediately at the end of procedure

• Duration of Anesthesia

  At procedure completion

Study Arms (1)

treatment

EXPERIMENTAL

aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)

Device: Implantation of the Bifurcated Multilayer Flow Modulator

Interventions

Implantation of the Bifurcated Multilayer Flow Modulator DEVICE

Also known as: BMFM, BMFM kit

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cardiatis: lead

Study Sites (7)

Hôpitaux IRIS Sud Molière Longchamps

Brussels, Uccle, 1190, Belgium

Location

City Hospital Clinic

Sofia, Bulgaria

Location

CMC Coeur et Vaisseaux

Salé, 11150, Morocco

Location

ELYTIS Hospital: Spital Multidisciplinar şi Policlinică

Iași, 700010, Romania

Location

European Hospital Polisano

Sibiu, 550172, Romania

Location

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

Maribor University Medical Centre

Maribor, Slovenia

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

The significant percentage of subjects lost to follow-up beyond the 12-month follow-up visit limit the reliability of the conclusions that can be drawn beyond this study timepoint.

Results Point of Contact

• Title: Pierre DOUETTE
• Organization: Cardiatis S.A.

info@intressavascular.com

+32 81 719 941

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 19, 2017
• Study Start: April 11, 2014
• Primary Completion: August 7, 2018
• Study Completion: December 7, 2023
• Last Updated: September 3, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); BE (1); BU (1); MO (1); RO (2)