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Valiant Evo International Clinical Trial

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: NCT02625324
Recruitment Status : Active, not recruiting
First Posted : December 9, 2015
Results First Posted : March 15, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of the Valiant Evo International 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 System Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valiant Evo International Clinical Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular repair
Valiant Evo Thoracic Stent Graft System
Device: Valiant Evo Thoracic Stent Graft System
Procedure: thoracic endovascular aneurysm repair (TEVAR)




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. Safety and Effectiveness Outcome [ Time Frame: 48 month ]

    Safety and effectiveness outcome measure 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.


  7. 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: 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, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks.



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.


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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 Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study
  3. Subject presents a 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 MRI 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)
    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, 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

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): NCT02625324


Locations
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Canada
London Health Sciences Centre - Victoria Hospital
London, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Quebec, Canada
Denmark
Odense Universitetshospital
Odense, Denmark
France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Italy
Policlinico Sant' Orsola - Malpighi
Bologna, Italy
IRCCS Ca' Granda Ospendale Maggiore Policlinico
Milano, Italy
Ospedale San Raffaele - Milano
Milano, Italy
Università di Perugia - Ospedale S.M. Della Misericordia
Perugia, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Netherlands
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, United Kingdom
Imperial College Healthcare NHS Trust - St Mary's Hospital
London, United Kingdom
Saint George's Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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Principal Investigator: Fabio Verzini, Prof. A.O.U. Citta della Salute e della Scienza
  Study Documents (Full-Text)

Documents provided by Medtronic Endovascular:
Study Protocol  [PDF] September 22, 2017
Statistical Analysis Plan  [PDF] November 1, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02625324    
Other Study ID Numbers: 10219493DOC
First Posted: December 9, 2015    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases