COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections (MONA-LSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738124
Recruitment Status : Withdrawn (Production of the medical device was stopped)
First Posted : November 13, 2018
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Medtronic Vascular
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Device: Valiant Mona LSA Thoracic Stent Graft System Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Valiant Mona LSA Thoracic Stent Graft System
The Valiant Mona LSA Thoracic Stent Graft System is administered.
Device: Valiant Mona LSA Thoracic Stent Graft System
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.




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. Aorta related mortality [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of aorta related mortality

  2. Stroke [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of stroke

  3. Paraplegia [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of paraplegia

  4. Left arm/hand ischemia [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of left arm/hand ischemia

  5. Effectiveness (Successful exclusion of the aneurysm) [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Successful exclusion of the aneurysm

  6. Effectiveness (patency) [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    False lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)

  7. Duration of the intervention [ Time Frame: Day 0 ]
    Duration of the intervention

  8. Necessary time for the branch placement [ Time Frame: Day 0 ]
    Necessary time for the branch placement

  9. Characteristics of the intervention (general anaesthesia) [ Time Frame: Day 0 ]
    General anaesthesia performing

  10. Characteristics of the intervention (blood loss) [ Time Frame: Day 0 ]
    Blood loss volume

  11. Characteristics of the intervention (transfusion) [ Time Frame: Day 0 ]
    Transfusion performing

  12. Duration of the stay in intensive care [ Time Frame: Day 0 ]
    Duration of the stay in intensive care

  13. Duration of the hospitalization [ Time Frame: Day 0 ]
    Duration of the hospitalization

  14. Characteristics of the hospitalization (intraoperative complications) [ Time Frame: Day 0 ]
    Occurrence of intraoperative complications

  15. Quality of life with EuroQol-5D [ Time Frame: Baseline, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    The quality of life will be measured with the EuroQol-5D (5 levels) questionnaire

  16. Minor adverse events [ Time Frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of minor adverse events

  17. Serious adverse events [ Time Frame: 1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of serious adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738124


Locations
Layout table for location information
France
Hôpital Timone Adultes
Marseille, France, 13385
CHU Toulouse, Hôpital Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Medtronic Vascular
Investigators
Layout table for investigator information
Principal Investigator: Hervé ROUSSEAU, MD University Hospital of Toulouse
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03738124    
Other Study ID Numbers: RC31/18/0234
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
stent graft
branch stent graft
thoracic aneurysm
endovascular aortic repair
aortic dissection
Valiant Mona LSA Thoracic Stent Graft System
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm, Dissecting
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases