Safety and Efficacy of Valiant Mona LSA Stent Graft System

Covidien

Status

Completed

Conditions

Thoracic Aortic Aneurysms

Treatments

Device: Valiant Mona LSA Stent Graft System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01839695

10086370DOCRev1C

Details and patient eligibility

About

The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is at least 18 years of age.
The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
Subject must be considered a candidate for revascularization of the LSA.
Subject has a DTA which will require coverage of the LSA
Subject's anatomy must meet the anatomical criteria to receive that implanted device

Exclusion criteria

Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta.
Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL
Subject is a pregnant female.
Enrollment in another clinical study
Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months.
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has a known allergy or intolerance to the device components.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.