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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03024554
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiatis

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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracoabdominal Device: Implantation of the Bifurcated Multilayer Flow Modulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).
Actual Study Start Date : April 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment
aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
Device: Implantation of the Bifurcated Multilayer Flow Modulator
Other Names:
  • BMFM
  • BMFM kit




Primary Outcome Measures :
  1. Number of patients with unruptured aneurysm [ Time Frame: 12 months ]
    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.

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

Secondary Outcome Measures :
  1. Number of branches and collaterals patent [ Time Frame: 12 months ]
    The patency of branches will be evaluated as follows: the number of branches patent will be evaluated on the total number of branches covered by the device (baseline data)

  2. Mortality 30 days, 6 months and 1 year not aneurysm-related [ Time Frame: 30 days, 6 months and 12 months ]
  3. Number of Major Adverse Events [ Time Frame: 12 months ]
    Number of patients with Major Adverse Evens

  4. Technical success [ Time Frame: The technical success is evaluated/recorded post-procedure and presented in the 12 months report. ]
    successful delivery and deployment of the BMFM® kit

  5. 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. ]
    descriptive statistics on Anesthesia time (min)

  6. 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. ]
    Descriptive Statistics on fluoroscopy time (min)procedure time; time to hospital discharge

  7. 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. ]
    Descriptive Statistics on contrast product volume (ml)

  8. 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. ]
    Descriptive Statistics on contrast Estimated Blood loss (ml)

  9. 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. ]
    Descriptive Statistics on procedure time (min); time to hospital discharge

  10. 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. ]
    Descriptive Statistics on time to hospital discharge (days).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024554


Locations
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Belgium
Hôpitaux IRIS Sud Molière Longchamps
Bruxelles, Uccle, Belgium, 1190
Bulgaria
City Hospital Clinic
Sofia, Bulgaria
Morocco
CMC Coeur et Vaisseaux
Sale, Morocco, 11150
Romania
ELYTIS Hospital: Spital Multidisciplinar şi Policlinică
Iaşi, Romania, 700010
European Hospital Polisano
Sibiu, Romania, 550172
Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia
Maribor University Medical Centre
Maribor, Slovenia
Sponsors and Collaborators
Cardiatis
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Responsible Party: Cardiatis
ClinicalTrials.gov Identifier: NCT03024554    
Other Study ID Numbers: 12-2013
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cardiatis:
aortic aneurysm involving iliac arteries
abdominal aortic aneurysm
MFM
Multilayer Flow Modulator
Multilayer Stent
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases