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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: January 31, 2017
Last verified: February 2017
April 11, 2013
January 31, 2017
April 2013
February 2014   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Primary Safety Endpoint [ Time Frame: 1 month ]
Cumulative Major Adverse events (including aneurysm-related mortality, stroke, paraplegia, and left arm/hand ischemia)
Complete list of historical versions of study NCT01839695 on ClinicalTrials.gov Archive Site
Not Provided
Endoleak [ Time Frame: 60 months ]
Endoleak of all types from the stent graft
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
Intervention Model: Single Group Assignment
Masking: No masking
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
Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT01839695
10086370DOCRev1C
No
Not Provided
Not Provided
Not Provided
Medtronic Endovascular
Medtronic Endovascular
Not Provided
Principal Investigator: Eric Roselli, MD The Cleveland Clinic
Medtronic Endovascular
February 2017

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