Safety and Efficacy of Valiant Mona LSA Stent Graft System

Thoracic Aortic Aneurysms Clinical Trial

Official title:

Valiant Mona LSA Stent Graft System Early Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839695
• Other study ID #: 10086370DOCRev1C
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysms

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