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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01839695
Other study ID # 10086370DOCRev1C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date December 2018

Study information

Verified date June 2023
Source Medtronic Cardiovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).The study is intended to assess safety and performance of the device acutely and at 30 days.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date December 2018
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
Valiant Mona LSA Stent Graft System
All subjects will be implanted with this device

Locations

Country Name City State
United Kingdom St George's Vascular Institute, St. George's Hospital London
United States Sanger Heart and Vascular Institute Charlotte North Carolina
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Safety Observation - Rate of Major Adverse Events (MAEs) Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia. 1 month
Primary Primary Effectiveness Observation Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit. 1 month
See also
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Completed NCT00604799 - VALOR: The Talent Thoracic Stent Graft System Clinical Study Phase 2/Phase 3
Recruiting NCT03142074 - Biomechanical and Microstructural Properties of Ascending Aortic Aneurysms
Completed NCT00435942 - Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft N/A
Terminated NCT00805948 - Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE) N/A