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Safety and Efficacy of Valiant Mona LSA Stent Graft System

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. Identifier: NCT01839695
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : October 29, 2014
Last Update Posted : August 6, 2019
Information provided by (Responsible Party):
Medtronic Endovascular

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valiant Mona LSA Stent Graft System Early Feasibility Study
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Valiant Mona LSA Stent Graft System
TEVAR procedure using Medtronic Stent Graft
Device: Valiant Mona LSA Stent Graft System
All subjects will be implanted with this device

Primary Outcome Measures :
  1. Primary Safety Observation - Rate of Major Adverse Events (MAEs) [ Time Frame: 1 month ]
    Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.

  2. Primary Effectiveness Observation [ Time Frame: 1 month ]
    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.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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 identifier (NCT number): NCT01839695

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United States, North Carolina
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28203
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 27465
United Kingdom
St George's Vascular Institute, St. George's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic Endovascular
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Principal Investigator: Eric Roselli, MD The Cleveland Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medtronic Endovascular Identifier: NCT01839695    
Other Study ID Numbers: 10086370DOCRev1C
First Posted: April 25, 2013    Key Record Dates
Results First Posted: October 29, 2014
Last Update Posted: August 6, 2019
Last Verified: July 2019
Keywords provided by Medtronic Endovascular:
Thoracic Aneurysm
Endovascular Aortic Repair
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases