Aortic Aneurysm, ThoracicMONA-LSANCT03738124
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
A study testing Valiant Mona LSA Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Valiant Mona LSA Thoracic Stent Graft System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2019to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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 descending thoracic aneurysm (DTA) which will require coverage of the LSA
- Subject has a healthy, non-diseased aortic proximal seal zone of at least 10 mm from the left carotid to the LSA and at least 5 mm landing zone distal to the LSA and proximal to the start of the aneurysm/ulcer/or the proximal entry tear for dissection.
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- Subject has a non-diseased aortic diameter between 25 mm and 42 mm (fusiform/saccular aneurysms or penetrating ulcers) or 28 mm to 44 mm (chronic type B dissections),
- Subject has a 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
- Subject has patent brachial arteries, iliac or femoral arteries (without circumferential calcifications and a diameter of ≥ 10mm), or can tolerate a conduit that will allow endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for treatment.
- Subject has a condition requiring prospective revascularization of the LSA
Who cannot join
- Subject has an aneurysmal, tortuous, or atherosclerotic LSA, conflicting the branch graft insertion.
- Subject has an aortic atheroma classified as grade IV or grade V.
- Subject has prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites.
- 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 or breastfeeding female.
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- 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 coronary artery disease with unstable angina and 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 has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Timone Adultes
Marseille, 13385
CHU Toulouse, Hôpital Rangueil
Toulouse, 31059
About this study
To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.
Read the detailed description
Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). To ensure adequate seal of currently available off-the-shelf stent grafts, 20 mm of healthy aorta is recommended between the proximal neck of the aneurysm and the leading edge of the stent graft. Stent graft placement can be facilitated by extending the proximal landing zone into the arch and covering the LSA; however, there may be a higher risk of serious neurologic outcomes (cerebral and paraplegia), although this is still a matter of debate. Serious risks are also known to accompany subclavian revascularization, which may involve bypass or transposition. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm.
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 1-month visit in the identified subject population (Aneurysms and chronic, Type B dissections). A follow up of this population will be annually during 5 years.
This pilot, non-randomized, single-arm prospective study will concern 20 patients. Inclusion criteria required patients with a thoracic aortic aneurysm (TAA) or dissection with an indication of a stent-Graft insertion. Primary end points will be aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Technical success will be assessed by imaging at 1 month, 6 months then annually during 5 years.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Valiant Mona LSA Thoracic Stent Graft System
- Keywords
- stent graft, branch stent graft, thoracic aneurysm, endovascular aortic repair, aortic dissection, Valiant Mona LSA Thoracic Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection
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
The Valiant Mona LSA device is a modular two-component system consisting of a main stent graft (MSG) and a branch stent graft (BSG), delivered separately, designed to maintain LSA perfusion. Briefly, under general anesthesia and after heparin injection, a MSG access is achieved via a femoral artery. A Through-and-through wire access for delivery of the BSG is achieved via a brachial artery. After the placement of the main aortic stent graft in the arch with the cuff at the level of the ostium of the LSA, the BSG is placed through a femoral access.
| Study group | Role | What they receive |
|---|---|---|
| Valiant Mona LSA Thoracic Stent Graft System | Experimental | The Valiant Mona LSA Thoracic Stent Graft System is administered. 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.
Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)
Composite endpoint defined as the occurrence of one of the following events: aorta related mortality, stroke, paraplegia, left arm/hand ischemia
Measured: 1 month
Effectiveness
Effectiveness defined as technical success and successful exclusion of the aneurysm or false lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)
Measured: 1 month
Secondary outcomes (17)
Aorta related mortality
Occurrence of aorta related mortality
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Stroke
Occurrence of stroke
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Paraplegia
Occurrence of paraplegia
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Left arm/hand ischemia
Occurrence of left arm/hand ischemia
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Effectiveness (Successful exclusion of the aneurysm)
Successful exclusion of the aneurysm
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Effectiveness (patency)
False lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)
Measured: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Duration of the intervention
Duration of the intervention
Measured: Day 0
Necessary time for the branch placement
Necessary time for the branch placement
Measured: Day 0
Characteristics of the intervention (general anaesthesia)
General anaesthesia performing
Measured: Day 0
Characteristics of the intervention (blood loss)
Blood loss volume
Measured: Day 0
Characteristics of the intervention (transfusion)
Transfusion performing
Measured: Day 0
Duration of the stay in intensive care
Duration of the stay in intensive care
Measured: Day 0
Duration of the hospitalization
Duration of the hospitalization
Measured: Day 0
Characteristics of the hospitalization (intraoperative complications)
Occurrence of intraoperative complications
Measured: Day 0
Quality of life with EuroQol-5D
The quality of life will be measured with the EuroQol-5D (5 levels) questionnaire
Measured: Baseline, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Minor adverse events
Occurrence of minor adverse events
Measured: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Serious adverse events
Occurrence of serious adverse events
Measured: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Production of the medical device was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular
- Responsible party
- Sponsor
- Investigators
- Hervé ROUSSEAU, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738124
- Sponsor's protocol ID
- RC31/18/0234
- Acronym
- MONA-LSA
- Status last verified
- Aug 2020
- First submitted
- 8 Nov 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. 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 Thoracic Aortic Aneurysms and Chronic Dissections
- ClinicalTrials.gov ID
- NCT03738124
- Acronym / sponsor ID
- MONA-LSA / RC31/18/0234
- Conditions
- Aortic Aneurysm, Thoracic
- Keywords
- stent graft, branch stent graft, thoracic aneurysm, endovascular aortic repair, aortic dissection, Valiant Mona LSA Thoracic Stent Graft System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Production of the medical device was stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Medtronic Vascular
- Study start
- Jan 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.
Detailed description
Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). To ensure adequate seal of currently available off-the-shelf stent grafts, 20 mm of healthy aorta is recommended between the proximal neck of the aneurysm and the leading edge of the stent graft. Stent graft placement can be facilitated by extending the proximal landing zone into the arch and covering the LSA; however, there may be a higher risk of serious neurologic outcomes (cerebral and paraplegia), although this is still a matter of debate. Serious risks are also known to accompany subclavian revascularization, which may involve bypass or transposition. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm.
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 1-month visit in the identified subject population (Aneurysms and chronic, Type B dissections). A follow up of this population will be annually during 5 years.
This pilot, non-randomized, single-arm prospective study will concern 20 patients. Inclusion criteria required patients with a thoracic aortic aneurysm (TAA) or dissection with an indication of a stent-Graft insertion. Primary end points will be aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Technical success will be assessed by imaging at 1 month, 6 months then annually during 5 years.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valiant Mona LSA Thoracic Stent Graft System | Experimental | Device: Valiant Mona LSA Thoracic Stent Graft SystemThe Valiant Mona LSA Thoracic Stent Graft System is administered. |
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
- 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 descending thoracic aneurysm (DTA) which will require coverage of the LSA
Key exclusion criteria (16 listed)
- Subject has an aneurysmal, tortuous, or atherosclerotic LSA, conflicting the branch graft insertion.
- Subject has an aortic atheroma classified as grade IV or grade V.
- Subject has prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites.
- 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.
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 SystemThe Valiant Mona LSA device is a modular two-component system consisting of a main stent graft (MSG) and a branch stent graft (BSG), delivered separately, designed to maintain LSA perfusion. Briefly, under general anesthesia and after heparin injection, a MSG access is achieved via a femoral artery. A Through-and-through wire access for delivery of the BSG is achieved via a brachial artery. After the placement of the main aortic stent graft in the arch with the cuff at the level of the ostium of the LSA, the BSG is placed through a femoral access. | Device | Valiant Mona LSA Thoracic Stent Graft System |
Primary outcome
Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)
Time frame: 1 month
Composite endpoint defined as the occurrence of one of the following events: aorta related mortality, stroke, paraplegia, left arm/hand ischemia
Effectiveness
Time frame: 1 month
Effectiveness defined as technical success and successful exclusion of the aneurysm or false lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)
17 secondary outcomes
Aorta related mortality
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Stroke
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Paraplegia
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Left arm/hand ischemia
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Effectiveness (Successful exclusion of the aneurysm)
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Effectiveness (patency)
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Duration of the intervention
Time frame: Day 0
Necessary time for the branch placement
Time frame: Day 0
Characteristics of the intervention (general anaesthesia)
Time frame: Day 0
Characteristics of the intervention (blood loss)
Time frame: Day 0
Characteristics of the intervention (transfusion)
Time frame: Day 0
Duration of the stay in intensive care
Time frame: Day 0
Duration of the hospitalization
Time frame: Day 0
Characteristics of the hospitalization (intraoperative complications)
Time frame: Day 0
Quality of life with EuroQol-5D
Time frame: Baseline, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Minor adverse events
Time frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Serious adverse events
Time frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Hervé ROUSSEAU, MD principal investigator
University Hospital of Toulouse
2 sites 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, run by University Hospital, Toulouse at 2 sites in France.
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 16 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: withdrawn, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia) (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?
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 26 Aug 2020.