Safety and Efficacy of Valiant Mona LSA Stent Graft System

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01839695
First received: April 11, 2013
Last updated: January 13, 2014
Last verified: January 2014

April 11, 2013
January 13, 2014
April 2013
February 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01839695 on ClinicalTrials.gov Archive Site
Endoleak [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Endoleak of all types from the stent graft
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Valiant Mona LSA Stent Graft System
Valiant Mona LSA Stent Graft System Early Feasibility Study

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Aortic Aneurysms
Device: Valiant Mona LSA Stent Graft System
All subjects will be implanted with this device
Experimental: Valiant Mona LSA Stent Graft System
TEVAR procedure using Medtronic Stent Graft
Intervention: Device: Valiant Mona LSA Stent Graft System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
February 2019
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01839695
10086370DOCRev1C
No
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Eric Roselli, MD The Cleveland Clinic
Medtronic Endovascular
January 2014

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