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

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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Recruitment Status : Withdrawn (Production of the medical device was stopped)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

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date August 26, 2020
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2018)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Safety events [ 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Aorta related mortality [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of aorta related mortality
  • Stroke [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of stroke
  • Paraplegia [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]
    Occurrence of paraplegia
  • 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
  • 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
  • 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)
  • Duration of the intervention [ Time Frame: Day 0 ]
    Duration of the intervention
  • Necessary time for the branch placement [ Time Frame: Day 0 ]
    Necessary time for the branch placement
  • Characteristics of the intervention (general anaesthesia) [ Time Frame: Day 0 ]
    General anaesthesia performing
  • Characteristics of the intervention (blood loss) [ Time Frame: Day 0 ]
    Blood loss volume
  • Characteristics of the intervention (transfusion) [ Time Frame: Day 0 ]
    Transfusion performing
  • Duration of the stay in intensive care [ Time Frame: Day 0 ]
    Duration of the stay in intensive care
  • Duration of the hospitalization [ Time Frame: Day 0 ]
    Duration of the hospitalization
  • Characteristics of the hospitalization (intraoperative complications) [ Time Frame: Day 0 ]
    Occurrence of intraoperative complications
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
Official Title  ICMJE Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Aortic Aneurysm, Thoracic
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Valiant Mona LSA Thoracic Stent Graft System
The Valiant Mona LSA Thoracic Stent Graft System is administered.
Intervention: Device: Valiant Mona LSA Thoracic Stent Graft System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 24, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
20
Estimated Study Completion Date  ICMJE February 2026
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738124
Other Study ID Numbers  ICMJE RC31/18/0234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Medtronic Vascular
Investigators  ICMJE
Principal Investigator: Hervé ROUSSEAU, MD University Hospital of Toulouse
PRS Account University Hospital, Toulouse
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP