ClinicalTrials.gov
ClinicalTrials.gov Menu

Valiant Evo US Clinical Trial (VEVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02652949
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Device: Valiant Evo Thoracic Stent Graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valiant Evo US Clinical Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Valiant Evo Thoracic Stent Graft
Subjects treated with the Valiant Evo Thoracic Stent Graft, via implantation by the Valiant Evo Thoracic Stent Graft System
Device: Valiant Evo Thoracic Stent Graft



Primary Outcome Measures :
  1. Access and/or deployment failures [ Time Frame: 30 Days ]
    Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced access and/or deployment failures

  2. Major device effect (MDE) [ Time Frame: 30 Days ]
    Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced Major Device Effect


Secondary Outcome Measures :
  1. Peri-Operative Mortality [ Time Frame: 30 Days ]
    Mortality within 30 days

  2. All Adverse Events [ Time Frame: 30 Days ]
    AEs within 30 days

  3. All Adverse Events [ Time Frame: 183 Days ]
    AEs within 183 days

  4. All Adverse Events [ Time Frame: 365 Days ]
    AEs within 365 days

  5. Secondary procedures [ Time Frame: 30 days ]
    Secondary procedures within 30 days

  6. Secondary procedures [ Time Frame: 183 days ]
    Secondary procedures within 183 days

  7. Secondary procedures [ Time Frame: 365 days ]
    Secondary procedures within 365 days

  8. Loss of Stent Graft Patency [ Time Frame: 30 days ]
    Loss of stent graft patency within 30 days

  9. Loss of Stent Graft Patency [ Time Frame: 6 months ]
    Loss of stent graft patency within 6 months

  10. Loss of Stent Graft Patency [ Time Frame: 12 months ]
    Loss of stent graft patency within 12 months

  11. Endoleaks [ Time Frame: 30 days ]
    Endoleaks within 30 days

  12. Endoleaks [ Time Frame: 6 months ]
    Endoleaks within 6 months

  13. Endoleaks [ Time Frame: 12 months ]
    Endoleaks within 12 months

  14. Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 6 months ]
    Aneurysm expansion between 1 month and 6 months

  15. Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 12 months ]
    Aneurysm expansion between 1 month and 12 months

  16. All cause mortality [ Time Frame: 183 days ]
    All cause mortality within 183 days

  17. All cause mortality [ Time Frame: 365 days ]
    All cause mortality within 365 days

  18. Aneurysm-related mortality [ Time Frame: 183 days ]
    Aneurysm related mortality within 183 days

  19. Aneurysm-related mortality [ Time Frame: 365 days ]
    Aneurysm related mortality within 365 days

  20. Major Device Effects [ Time Frame: 183 days ]
    MDEs within 183 days

  21. Major Device Effects [ Time Frame: 365 days ]
    MDEs within 365 days



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥18 years old.
  2. Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.
  3. Subject presents a DTAA which is localized below the ostium of LSA and above the ostium of celiac trunk
  4. Subject has a DTAA that is one of the following:

    1. A fusiform aneurysm with a maximum diameter that:

      • is ≥ 50 mm and/or:
      • is > 2 times the diameter of the non-aneurysmal thoracic aorta and/or:
      • is < 50 mm and has grown ≥ 5 mm within previous 12 months
    2. A saccular aneurysm or a penetrating atherosclerotic ulcer
  5. Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced MRA obtained within four (4) months prior to implant procedure:

    1. Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm;
    2. Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration) distal to the left common carotid artery (LCCA). Note: Proximal aortic neck length may include covering the LSA (with or without discretionary revascularization) when necessary to optimize device fixation and maximize aortic neck length. If occlusion of the LSA ostium is required to obtain adequate neck length for fixation and sealing, transposition or bypass to the LSA may be warranted.
    3. Distal non-aneurysmal aortic neck length must be ≥ 20 mm
  6. Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.

Exclusion Criteria:

  1. Subject has a life expectancy of less than 1 year
  2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.
  3. Subject is pregnant.
  4. Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
  5. Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm).
  6. Subject has a mycotic aneurysm.
  7. Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm.
  8. Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
  9. Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch.
  10. Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
  11. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
  12. Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery or the left common carotid artery or the celiac trunk.
  13. Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
  14. Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft.
  15. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
  16. Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
  17. Subject has had a MI within 3 months of the procedure.
  18. Subject has had a CVA within 3 months of the procedure.
  19. Subject has a known allergy or intolerance to the device materials
  20. Subject has a known allergy to anesthetic drugs
  21. Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment.
  22. Subject has active or systemic infection at the time of the index procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652949


Locations
United States, Arizona
Abrazo Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
Stanford Hospital
Stanford, California, United States, 94305
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Ali Azizzadeh, MD Memorial Hermann Medical Center

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02652949     History of Changes
Other Study ID Numbers: 10219498DOC
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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