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Valiant Evo US Clinical Trial (VEVO)

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ClinicalTrials.gov Identifier: NCT02652949
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Results First Posted : February 26, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 12, 2016
Results First Submitted Date  ICMJE December 10, 2018
Results First Posted Date  ICMJE February 26, 2019
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure [ Time Frame: 30 Days ]
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • 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
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
  • Safety and Effectiveness Outcome [ Time Frame: 30 Days ]
    Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
  • Safety and Effectiveness Outcome [ Time Frame: 6 month ]
    Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
  • Safety and Effectiveness Outcome [ Time Frame: 12 Month ]
    Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
  • Safety and Effectiveness Outcome [ Time Frame: 24 Month ]
    Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
  • Safety and Effectiveness Outcome [ Time Frame: 36 Month ]
    Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
  • Safety and Effectiveness Outcome [ Time Frame: 48 Month ]
    Safety and Effectiveness outcome measures between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
  • Safety and Effectiveness Outcome [ Time Frame: 60 Month ]
    Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Peri-Operative Mortality [ Time Frame: 30 Days ]
  • All Adverse Events [ Time Frame: 30 Days ]
  • All Adverse Events [ Time Frame: 183 Days ]
  • All Adverse Events [ Time Frame: 365 Days ]
  • Secondary procedures [ Time Frame: 30 days ]
  • Secondary procedures [ Time Frame: 183 days ]
  • Secondary procedures [ Time Frame: 365 days ]
  • Loss of Stent Graft Patency [ Time Frame: 30 days ]
  • Loss of Stent Graft Patency [ Time Frame: 6 months ]
  • Loss of Stent Graft Patency [ Time Frame: 12 months ]
  • Endoleaks [ Time Frame: 30 days ]
  • Endoleaks [ Time Frame: 6 months ]
  • Endoleaks [ Time Frame: 12 months ]
  • Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 6 months ]
  • Aneurysm expansion > 5 mm relative to 1 month visit [ Time Frame: 12 months ]
  • All cause mortality [ Time Frame: 183 days ]
  • All cause mortality [ Time Frame: 365 days ]
  • Aneurysm-related mortality [ Time Frame: 183 days ]
  • Aneurysm-related mortality [ Time Frame: 365 days ]
  • Major Device Effects [ Time Frame: 183 days ]
  • Major Device Effects [ Time Frame: 365 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valiant Evo US Clinical Trial
Official Title  ICMJE Valiant Evo US Clinical Trial
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.
Detailed Description Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order to obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Aneurysm, Thoracic
Intervention  ICMJE Device: Valiant Evo Thoracic Stent Graft System
Procedure: thoracic endovascular aneurysm repair (TEVAR)
Study Arms  ICMJE Experimental: Endovascular Repair
Valiant Evo Thoracic Stent Graft System
Intervention: Device: Valiant Evo Thoracic Stent Graft System
Publications * Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 Descending Thoracic Aortic Aneurysm (DTAA) which is localized below the ostium of Left Subclavian Artery (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 Magnetic Resonance Angiogram (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 Myocardial Infarction (MI) within 3 months of the procedure.
  18. Subject has had a Cerebrovascular Accident (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02652949
Other Study ID Numbers  ICMJE 10219498DOC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Cardiovascular
Study Sponsor  ICMJE Medtronic Cardiovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali Azizzadeh, MD Memorial Hermann Medical Center
PRS Account Medtronic Cardiovascular
Verification Date June 2021

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