Status:
COMPLETED
Safety and Efficacy of Valiant Mona LSA Stent Graft System
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Thoracic Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01839695
Start Date
April 1 2013
End Date
December 1 2018
Last Update
July 3 2023
Active Locations (3)
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1
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28203
2
Cleveland Clinic
Cleveland, Ohio, United States, 27465
3
St George's Vascular Institute, St. George's Hospital
London, United Kingdom