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Safety and Efficacy of Valiant Mona LSA Stent Graft System

Primary Purpose

Thoracic Aortic Aneurysms

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Valiant Mona LSA Stent Graft System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysms focused on measuring Thoracic Aneurysm, Endovascular Aortic Repair, TEVAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanger Heart and Vascular Institute
  • Cleveland Clinic
  • St George's Vascular Institute, St. George's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valiant Mona LSA Stent Graft System

Arm Description

TEVAR procedure using Medtronic Stent Graft

Outcomes

Primary Outcome Measures

Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Primary Effectiveness Observation
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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2013
Last Updated
June 28, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01839695
Brief Title
Safety and Efficacy of Valiant Mona LSA Stent Graft System
Official Title
Valiant Mona LSA Stent Graft System Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysms
Keywords
Thoracic Aneurysm, Endovascular Aortic Repair, TEVAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valiant Mona LSA Stent Graft System
Arm Type
Experimental
Arm Description
TEVAR procedure using Medtronic Stent Graft
Intervention Type
Device
Intervention Name(s)
Valiant Mona LSA Stent Graft System
Intervention Description
All subjects will be implanted with this device
Primary Outcome Measure Information:
Title
Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Description
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Time Frame
1 month
Title
Primary Effectiveness Observation
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Roselli, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
27465
Country
United States
Facility Name
St George's Vascular Institute, St. George's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26483004
Citation
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.
Results Reference
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Safety and Efficacy of Valiant Mona LSA Stent Graft System

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