Evaluation of the Safety and Efficacy of the Multilayer Stent

NCT01756911 | Completed DMC

• 2 other identifiers: IC_0308_FRA2009-013678-42
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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.

Conditions

Aortic Aneurysm, Thoracoabdominal; Thoracoabdominal Aortic Aneurysm; Aortic Aneurysm, Thoracic

Keywords

MFM; Multilayer Flow Modulator; Multilayer stent; Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Number of patients with aneurysm exclusion

  12 months

Secondary Outcomes (2)

• Number of covered branches permeable

  12 months

• Number of patients with Serious Adverse Events

  12 months

Study Arms (1)

Thotaco-abdominal aneurysm

EXPERIMENTAL

MFM

Device: MFM

Interventions

MFM DEVICE

Implantation of the MFM

Also known as: Multilayer Flow Modulator, Multilayer stent

Thotaco-abdominal aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Age \> 80 years
• ASA (American Society of Anesthesiologists) score ≥ 3
• History of thoracic surgery or surgery of the abdominal aorta
• Coronary artery disease (history of angina or myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
• Heart failure
• Inoperable aortic stenosis
• LVEF (Left Ventricular Ejection Fraction) \<40%;
• chronic respiratory failure defined by one of the following criteria:
• FEV (Forced expiratory volume) \<1.2 l / sec;
• VC (Vital Capacity) \<50% of the predicted value according to age, sex and weight;

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiatis: lead

Study Sites (9)

Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Neurocardiologique

Bron, 69677, France

Location

Centre Hospitalier de La Région D'Annecy

Metz-Tessy, 74370, France

Location

Chu Brabois Nancy

Nancy, 54511, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

Pitie-Salpetriere

Paris, 75651, France

Location

CMC Parly II

Paris, 78150, France

Location

Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy

Quincy-sous-Sénart, 91480, France

Location

Hopital Universitaire Rangueil

Toulouse, 31059, France

Location

Related Publications (2)

• Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial. J Endovasc Ther. 2014 Feb;21(1):85-95. doi: 10.1583/13-4553R.1.

  PMID: 24502488 RESULT

• Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, Alsac JM, Leprince PN, Unterseeh T, Portocarrero E, Glock Y, Rousseau H; STRATO Investigators Group. Three-Year Outcomes With the Multilayer Flow Modulator for Repair of Thoracoabdominal Aneurysms: A Follow-up Report From the STRATO Trial. J Endovasc Ther. 2016 Oct;23(5):762-72. doi: 10.1177/1526602816653095. Epub 2016 Jun 8.

  PMID: 27280802 DERIVED

Related Links

• One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Jean-Noël Fabiani, Pr

  HEGP

  PRINCIPAL INVESTIGATOR

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: December 14, 2012
• First Posted: December 28, 2012
• Study Start: March 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

FR (9)