Thoracic Aortic AneurysmsNCT01839695
Safety and Efficacy of Valiant Mona LSA Stent Graft System
A study testing Valiant Mona LSA Stent Graft System in people with Thoracic Aortic Aneurysms, run by Medtronic Cardiovascular at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysms
- What is being tested?
- Valiant Mona LSA Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2013to Dec 2018
- Phase
- Interventional
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.
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 27465
United Kingdom1 site
St George's Vascular Institute, St. George's Hospital
London
About this study
Official title: Valiant Mona LSA Stent Graft System Early Feasibility Study
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.
- Conditions
- Thoracic Aortic Aneurysms
- Being tested
- Valiant Mona LSA Stent Graft System
- Keywords
- Thoracic Aneurysm, Endovascular Aortic Repair, TEVAR
- Medical subject headings
- 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 Stent Graft SystemDevice
All subjects will be implanted with this device
| Study group | Role | What they receive |
|---|---|---|
| Valiant Mona LSA Stent Graft System | Experimental | TEVAR procedure using Medtronic Stent Graft Receives: Device: Valiant Mona LSA Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionDec 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic AneurysmsStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Roselli, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839695
- Sponsor's protocol ID
- 10086370DOCRev1C
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2013
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23.
PubMed 26483004