Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections

NCT02365467 | Completed Results DMC

• 1 other identifier: 10151194DOC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps. The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.

Conditions

Aortic Aneurysm, Thoracic, Chronic Type B Dissection

Keywords

TEVAR; Thoracic Aneurysm; Endovascular Aortic Repair; Type B Dissection

Outcome Measures

Primary Outcomes (2)

• 30 Day Composite Safety Endpoint

  Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality * Stroke * Paraplegia * Left Arm/Hand Ischemia

  1 month

• 30 Day Treatment Success

  Treatment success which is defined as technical success (the successful delivery and deployment of the Valiant Mona LSA Thoracic Stent Graft System in the planned location with no unintentional coverage of other vessels, assessed intra-operatively, and the removal of the delivery system) and successful exclusion of the aneurysm or false lumen while maintaining patency of the Main Stent Graft and Branch Stent Graft at 30 day visit. This endpoint is site reported.

  1 month

Study Arms (1)

Treatment with Valiant Mona LSA device

EXPERIMENTAL

Treatment with Valiant Mona LSA device

Device: Valiant Mona LSA Thoracic Stent Graft System

Interventions

Valiant Mona LSA Thoracic Stent Graft System DEVICE

Treatment with Valiant Mona LSA device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age.
• Subject understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
• Subject must be considered a candidate for revascularization of the LSA. Subject must be able to tolerate a surgical revascularization of the LSA.
• Subject has a TAA/PAU which will require coverage of the LSA and is:
• a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR
• a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic)
• Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm from the distal end of the LCC ostium to the beginning of the disease, including at least 10 mm between the LSA and the LCC.
• Subject has a non -diseased aortic proximal neck length of \>0mm distal to the LSA
• Subject has a non-diseased aortic diameter between 25 mm and 42 mm
• Subject has a non-diseased LSA with a diameter between 8 mm and 13 mm.
• Subject has sufficient landing zone within the LSA to accommodate the BSG without occlusion of any significant vessels
• Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
• Introducer sheath is required for all procedures.
• An iliac conduit is required for access if the above requirements are not met.
• Subject is at least 18 years of age.

You may not qualify if:

• Subjects will be excluded if they have conditions requiring prospective revascularization of the LSA including:
• Dominant left vertebral artery requiring revascularization
• Prior coronary artery bypass graft utilizing the left mammary artery requiring revascularization
• Incomplete circle of Willis or other neurological vasculature requiring revascularization
• Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
• Subject has an acute dissection of the descending thoracic aorta.
• Subject has an intramural hematoma of the descending thoracic aorta.
• Subject has prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites.
• Subject has circumferential calcification in the external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 10mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
• Subject requiring an aortic conduit or direct aortic access
• Subject has an aortic atheroma classified as grade IV or grade V.
• Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta \<30 days of implantation of investigational device or previous repair was a non-Medtronic device
• Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require intentional coverage of the left common carotid artery with the stent graft fabric.
• Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
• Subject is a pregnant female.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Alexa Glandon, Medtronic Clinical Study Manager
• Organization: Medtronic

alexa.a.glandon@medtronic.com

12624087021

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: April 16, 2015
• Primary Completion: September 20, 2019
• Study Completion: December 5, 2024
• Last Updated: August 17, 2025
• Results First Posted: October 21, 2022

Record last verified: 2025-08

Locations

US (1)