Safety and Efficacy of Valiant Mona LSA Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01839695
First received: April 11, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Thoracic Aortic Aneurysms
Device: Valiant Mona LSA Stent Graft System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valiant Mona LSA Stent Graft System Early Feasibility Study

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Cumulative Major Adverse events (including aneurysm-related mortality, stroke, paraplegia, and left arm/hand ischemia)


Secondary Outcome Measures:
  • Endoleak [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    Endoleak of all types from the stent graft


Enrollment: 9
Study Start Date: April 2013
Estimated Study Completion Date: February 2019
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839695

Locations
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
Investigators
Principal Investigator: Eric Roselli, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01839695     History of Changes
Other Study ID Numbers: 10086370DOCRev1C
Study First Received: April 11, 2013
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Thoracic Aneurysm
Endovascular Aortic Repair
TEVAR

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

ClinicalTrials.gov processed this record on October 20, 2014