NCT03024554

Brief Summary

To determine the safety and efficacy of the BMFM® kit in the use for the endovascular treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM® has CE mark approval for the aortic aneurysm treatment.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 7, 2024

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

January 5, 2017

Last Update Submit

February 6, 2024

Conditions

Aortic Aneurysm, AbdominalAortic Aneurysm, Thoracoabdominal

Keywords

aortic aneurysm involving iliac arteriesabdominal aortic aneurysmMFMMultilayer Flow ModulatorMultilayer Stent

Outcome Measures

Primary Outcomes (2)

  • Number of patients with unruptured aneurysm

    the prevention of aortic aneurysm rupture by the BMFM, in stabilizing it, will be evaluated with the number of patient presenting with unruptured aneurysm at the specified timepoint.

    12 months

  • Mortality 30 days, 6 months and 1 year aneurysm-related

    30 days, 6 months and 12 months

Secondary Outcomes (10)

  • Number of branches and collaterals patent

    12 months

  • Mortality 30 days, 6 months and 1 year not aneurysm-related

    30 days, 6 months and 12 months

  • Number of Major Adverse Events

    12 months

  • Technical success

    The technical success is evaluated/recorded post-procedure and presented in the 12 months report.

  • Procedural/in-hospital evaluations (Anesthesia time)

    The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.

  • +5 more secondary outcomes

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 ModulatorDEVICE
Also known as: BMFM, BMFM kit
treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, AbdominalAortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

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 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2022

Last Updated

February 7, 2024

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

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