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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardiatis
ClinicalTrials.gov Identifier:
NCT01756911
First received: December 14, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
Aortic Aneurysm, Thoracoabdominal
Thoracoabdominal Aortic Aneurysm
Aortic Aneurysm, Thoracic
Device: MFM

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation du Stent Multicouches Dans le Traitement Des anévrismes de l'Aorte Thoraco-abdominale

Resource links provided by NLM:


Further study details as provided by Cardiatis:

Primary Outcome Measures:
  • Number of patients with aneurysm exclusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of covered branches permeable [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of patients with Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thotaco-abdominal aneurysm
MFM
Device: MFM
Implantation of the MFM
Other Names:
  • Multilayer Flow Modulator
  • Multilayer stent

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756911

Locations
France
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
CMC Parly II
Paris, France, 78150
Hopital Europeen Georges-Pompidou
Paris, France, 75015
Pitie-Salpetriere
Paris, France, 75651
Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy
Quincy-sous-Sénart, France, 91480
Hopital Universitaire Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Cardiatis
Investigators
Principal Investigator: Jean-Noël Fabiani, Pr HEGP
  More Information

Additional Information:
Publications:
Responsible Party: Cardiatis
ClinicalTrials.gov Identifier: NCT01756911     History of Changes
Other Study ID Numbers: IC_0308_FRA, 2009-013678-42
Study First Received: December 14, 2012
Last Updated: April 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 17, 2014