CompletedNot Applicable

Evaluation of the Safety and Efficacy of the Multilayer Stent

France23 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

What they're measuring

Number of patients with aneurysm exclusion

Timeframe: 12 months

Trial details

NCT IDNCT01756911

SponsorCardiatis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

View on ClinicalTrials.gov More Aortic Aneurysm, Thoracoabdominal trials