Aortic Aneurysm, Thoracic Clinical Trial
— STRATOOfficial title:
Evaluation du Stent Multicouches Dans le Traitement Des anévrismes de l'Aorte Thoraco-abdominale
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Jean Minjoz | Besançon | |
France | Hopital Neurocardiologique | Bron | |
France | Centre Hospitalier de La Région D'Annecy | Metz-Tessy | |
France | Chu Brabois Nancy | Nancy | |
France | CMC Parly II | Paris | |
France | Hopital Europeen Georges-Pompidou | Paris | |
France | Pitie-Salpetriere | Paris | |
France | Institut Cardio-Vasculaire Paris Sud Hôpital Claude Galien À Quincy | Quincy-sous-Sénart | |
France | Hopital Universitaire Rangueil | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Cardiatis |
France,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with aneurysm exclusion | 12 months | No | |
Secondary | Number of covered branches permeable | 12 months | No | |
Secondary | Number of patients with Serious Adverse Events | 12 months | Yes |
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