Aortic Aneurysm, Thoracic, Chronic Type B DissectionNCT02365467

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

A study testing Valiant Mona LSA Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, Chronic Type B Dissection, run by Medtronic Cardiovascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
What is being tested?: Valiant Mona LSA Thoracic Stent Graft System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 16 Apr 2015to 5 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 Left Subclavian Artery (LSA). Subject must be able to tolerate a surgical revascularization of the LSA.
Subject has a chronic type B dissection which will require coverage of the LSA. A chronic type B dissection is defined as > 30 days from symptom onset and is complicated with an aortic diameter ≥ 5.5 cm or has progressive aortic enlargement (> 5 mm/year).
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 diameter between 28 mm to 44 mm.

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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 these requirements are not met.

Who cannot join

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.

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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.
Subject has a known allergy or intolerance to the device components.
Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL or is on dialysis.
Subject has a body habitus which prevents adequate visualization of the aorta.
Subject has coronary artery disease with unstable angina and who has not received treatment.
Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
Subject has active systemic infection and/or a mycotic aneurysm.
Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
Subject has a life expectancy of less than 1 year.
Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has had a cerebral vascular accident (CVA) within 3 months.
Subject has had a myocardial infarction (MI) within 3 months.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections

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.

Read the detailed description

The purpose of the clinical investigation is to assess the feasibility of the Valiant Mona LSA Thoracic Stent Graft System to repair fusiform/saccular aneurysms, penetrating ulcers and chronic type B dissections of the DTA in patients who require coverage of the LSA, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. Procedural information will be collected in order to enhance the current instructions for use and delivery and deployment steps.

The chronic Type B Dissection expansion subjects will be prospectively enrolled in support of a future premarket approval analysis for the Valiant Mona LSA device.

Conditions: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Being tested: Valiant Mona LSA Thoracic Stent Graft System
Keywords: TEVAR, Thoracic Aneurysm, Endovascular Aortic Repair, Type B Dissection
Medical subject headings: Aortic Aneurysm, Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valiant Mona LSA Thoracic Stent Graft SystemDevice

Study groups in NCT02365467
Study group	Role	What they receive
Treatment with Valiant Mona LSA device	Experimental	Treatment with Valiant Mona LSA device Receives: Device: Valiant Mona LSA Thoracic Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 20155 Dec 2024

First posted19 Feb 2015 (estimated)
Study start16 Apr 2015
Primary completion20 Sep 2019
Study completion5 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic Aneurysm, Thoracic, Chronic Type B DissectionStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02365467
Sponsor's protocol ID: 10151194DOC
Status last verified: Aug 2025
First submitted: 11 Feb 2015
Last updated: 17 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections
ClinicalTrials.gov ID: NCT02365467
Acronym / sponsor ID: 10151194DOC
Conditions: Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Keywords: TEVAR, Thoracic Aneurysm, Endovascular Aortic Repair, Type B Dissection
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: 16 Apr 2015 (actual)
Primary completion: 20 Sep 2019 (actual)
Study completion: 5 Dec 2024 (actual)
First posted: 19 Feb 2015 (estimated)
Results: Posted 21 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The chronic Type B Dissection expansion subjects will be prospectively enrolled in support of a future premarket approval analysis for the Valiant Mona LSA device.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with Valiant Mona LSA device	Experimental	Device: Valiant Mona LSA Thoracic Stent Graft SystemTreatment with Valiant Mona LSA device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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 Left Subclavian Artery (LSA). Subject must be able to tolerate a surgical revascularization of the LSA.
Subject has a chronic type B dissection which will require coverage of the LSA. A chronic type B dissection is defined as > 30 days from symptom onset and is complicated with an aortic diameter ≥ 5.5 cm or has progressive aortic enlargement (> 5 mm/year).
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

Key exclusion criteria (30 listed)

Subjects will be excluded if they have conditions requiring prospective revascularization of the LSA including:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Valiant Mona LSA Thoracic Stent Graft System	Device	Treatment with Valiant Mona LSA device

Primary outcome

30 Day Composite Safety Endpoint
Time frame: 1 month
Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality * Stroke * Paraplegia * Left Arm/Hand Ischemia
30 Day Treatment Success
Time frame: 1 month
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.

Results and safety

Results posted to the registry on 21 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endovascular Repair	32	29

Primary outcome: 30 Day Composite Safety Endpoint

Time frame: 1 month. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Endovascular Repair n = 30
Value	10.0 (2.1 to 26.5)

Population analysed: The analysis was performed on all enrolled subjects who were considered evaluable. The subjects were considered enrolled after arterial access is achieved and the Valiant Mona LSA Thoracic Stent Graft System was introduced into the vasculature. Subjects were evaluable if they had the event, or did not have the event and completed a follow-up 15 days or more after the index procedure.

Primary outcome: 30 Day Treatment Success

Time frame: 1 month. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Endovascular Repair n = 29
Value	62.1 (42.3 to 79.3)

Population analysed: The analysis was performed on all enrolled subjects who were considered evaluable. There were 3 patients who were not evaluable because they did not have the event and were missing at least one of the three components (technical success, successful exclusion at 30 days, or maintaining patency at the 30 day visit).

Adverse events

Time frame: Adverse Events and All-Cause Mortality through 5 years (05DEC2024). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endovascular Repair	30 of 32 (93.8%)	27 of 32 (84.4%)	9 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Valiant Mona LSA Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, Chronic Type B Dissection, run by Medtronic Cardiovascular at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 Day Composite Safety Endpoint (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02365467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.