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Completed

NCT Number: NCT01839695

Safety and Efficacy of Valiant Mona LSA Stent Graft System

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.

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Key information

Conditions

Thoracic Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St George's Vascular Institute, St. George's Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valiant Mona LSA Stent Graft System

Device

All subjects will be implanted with this device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

Valiant Mona LSA Stent Graft System Early Feasibility Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Apr 25, 2013
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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