Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT03024554
• Date of registration: 05/01/2017
• Prospective Registration: No
• Primary sponsor: Cardiatis
• Public title: Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®). STREAMLINER
• Scientific title: Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).
• Date of first enrolment: April 2014
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03024554
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Bulgaria, Italy, Morocco, Romania, Slovenia

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Aneurysm, Thoracoabdominal

Aortic Aneurysm, Abdominal

Intervention(s)

Device: Implantation of the Bifurcated Multilayer Flow Modulator

Primary Outcome(s)

Mortality 30 days, 6 months and 1 year aneurysm-related [Time Frame: 30 days, 6 months and 12 months]

Number of patients with unruptured aneurysm [Time Frame: 12 months]

Secondary Outcome(s)

Number of Major Adverse Events [Time Frame: 12 months]

Procedural/in-hospital evaluations (Anesthesia time) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Procedural/in-hospital evaluations (Estimated Blood loss) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Mortality 30 days, 6 months and 1 year not aneurysm-related [Time Frame: 30 days, 6 months and 12 months]

Procedural/in-hospital evaluations (time to hospital discharge) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Technical success [Time Frame: The technical success is evaluated/recorded post-procedure and presented in the 12 months report.]

Procedural/in-hospital evaluations (Constrast Volume) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Procedural/in-hospital evaluations (Fluoroscopy time) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Number of branches and collaterals patent [Time Frame: 12 months]

Procedural/in-hospital evaluations (procedure time) [Time Frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.]

Secondary ID(s)

12-2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors