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Evaluation of Valiant Mona LSA

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ClinicalTrials.gov Identifier: NCT02365467
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief 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. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps.

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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections
Study Start Date : April 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Valiant Mona LSA device Device: Valiant Mona LSA Thoracic Stent Graft System



Primary Outcome Measures :
  1. Primary Safety Observation, composite endpoint consisting of: •Aorta Related Mortality •Stroke •Paraplegia •Left Arm/Hand Ischemia [ 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

  2. Primary Effectiveness Observation defined as as technical success and successful exclusion of the aneurysm or false lumen [ 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 MSG and BSG at 30 day visit.



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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 approved by the Sponsor and by the IRB for this study.
  • 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 TAA/PAU which will require coverage of the LSA and is:

    • a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR
    • a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter);
  • 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 proximal neck length of >=5mm distal to the LSA
  • Subject has a non-diseased aortic diameter between 25 mm and 42 mm
  • 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 the above requirements are not met.

Exclusion Criteria

  • 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.
  • 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.
  • 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.
  • 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.

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): NCT02365467


Contacts
Contact: Greg Minisman 707-541-3279 greg.minisman@medtronic.com

Locations
United States, Alabama
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Aamir Shah, MD         
United States, Florida
University of Florida Shands Hospital Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Javairiah Fatima, MD         
United States, Georgia
Emory Healthcare Recruiting
Atlanta, Georgia, United States, 30322
Contact: William Jordan, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Frank Arko, MD         
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 27465
Contact: Eric Roselli, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Nimesh D Desai, MD PhD         
United States, Texas
Baylor St. Lukes Medical Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Joseph Coselli, MD         
Sub-Investigator: Ourania Preventza, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jean Panneton, MD         
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Eric Roselli, MD The Cleveland Clinic

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02365467     History of Changes
Other Study ID Numbers: 10151194DOC
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Medtronic Endovascular:
TEVAR
Thoracic Aneurysm
Endovascular Aortic Repair
Type B Dissection

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases