Evaluation of the Safety and Efficacy of the Multilayer Stent (STRATO)

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. Identifier: NCT01756911
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):

Brief Summary:

Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm Repair.

The objectives of the study is to determine the efficacy, safety and performance of the MFM and its delivery system in patients at high surgical risk presenting with a type II, III thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation, according to the Crawford classification.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracoabdominal Thoracoabdominal Aortic Aneurysm Aortic Aneurysm, Thoracic Device: MFM Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation du Stent Multicouches Dans le Traitement Des anévrismes de l'Aorte Thoraco-abdominale
Study Start Date : March 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Thotaco-abdominal aneurysm
Device: MFM
Implantation of the MFM
Other Names:
  • Multilayer Flow Modulator
  • Multilayer stent

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

Secondary Outcome Measures :
  1. Number of covered branches permeable [ Time Frame: 12 months ]
  2. Number of patients with Serious Adverse Events [ Time Frame: 12 months ]

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

Inclusion Criteria:

  • Age >18 years
  • Life expectancy ≥ 12 months
  • The patient or his legal representative has signed the informed consent form
  • Thoracoabdominal aneurysm type 2 or 3 with vital collaterals and requiring intervention to prevent its rupture according to the criteria defined by consensus ("Expert Consensus Document on the Treatment of Descending Thoracic Aortic Disease Using Endovascular Stent-Grafts", Ann Thorac Surg 2008;85:S1-41)
  • Contraindicated for open surgery, declared inoperable by the surgeon and anesthetist (statement signed by each doctor) and must have at least one of the following:

    1. Age > 80 years
    2. ASA (American Society of Anesthesiologists) score ≥ 3
    3. History of thoracic surgery or surgery of the abdominal aorta
    4. Coronary artery disease (history of angina or myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
    5. Heart failure
    6. Inoperable aortic stenosis
    7. LVEF (Left Ventricular Ejection Fraction) <40%;
    8. chronic respiratory failure defined by one of the following criteria:

      1. FEV (Forced expiratory volume) <1.2 l / sec;
      2. VC (Vital Capacity) <50% of the predicted value according to age, sex and weight;
      3. arterial blood gas analysis in the absence of oxygen: PaCO2 (Pression artérielle en CO2) > 45 mmHg or PaO2 (Pression artérielle en O2) <60 mmHg
      4. Oxygen therapy
    9. renal insufficiency if creatininaemia> 200 micromol / l before injection of contrast product;
    10. hostile abdomen, including presence of ascites or other signs of portal hypertension;
    11. obesity.
  • adequate arterial anatomy of aneurismal lesion access.

Exclusion Criteria:

  • medical contraindications to a local or general anesthesia and angiography;
  • Life expectancy less than one year, or clinical follow-up impossible;
  • congenital disorders of blood coagulation;
  • intercurrent infection;
  • allergy to aspirin, clopidogrel, or contrast agents;
  • patient(s) included in another clinical study;
  • patient pregnant or breastfeeding

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 identifier (NCT number): NCT01756911

Hopital Jean Minjoz
Besançon, France, 25030
Hopital Neurocardiologique
Bron, France, 69677
Centre Hospitalier de La Région D'Annecy
Metz-Tessy, France, 74370
Chu Brabois Nancy
Nancy, France, 54511
Hopital Europeen Georges-Pompidou
Paris, France, 75015
Paris, France, 75651
CMC Parly II
Paris, France, 78150
Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy
Quincy-sous-Sénart, France, 91480
Hopital Universitaire Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Principal Investigator: Jean-Noël Fabiani, Pr HEGP

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cardiatis Identifier: NCT01756911     History of Changes
Other Study ID Numbers: IC_0308_FRA
2009-013678-42 ( EudraCT Number )
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Cardiatis:
Multilayer Flow Modulator
Multilayer stent
Thoracoabdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases