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Trial record 16 of 97 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Valiant Evo International Clinical Trial

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ClinicalTrials.gov Identifier: NCT02625324
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : September 20, 2017
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. The Valiant Evo International Clinical Trial is a first-in human experience with the objective to provide clinical data for supporting CE marking via case series and descriptive statistics.

Condition or disease Intervention/treatment
Aortic Aneurysm, Thoracic Device: Valiant Evo Thoracic Stent Graft System

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valiant Evo International Clinical Trial
Actual Study Start Date : May 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Endovasculair 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 proportion of subjects who experienced: (a) Access and/or deployment failures; and/or (b) MDE [ Time Frame: within 30 days post index procedure ]

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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): NCT02625324


Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Audra Duncan, Dr.         
Université Laval Recruiting
Quebec, Canada
Contact: François Dagenais, Dr.         
Odense Universitetshospital Recruiting
Odense, Denmark
Contact: Anne-Sofie Brenoe, Dr.         
CHU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France
Contact: Canaud, Prof.         
Centre Chirurgical Marie Lannelongue Recruiting
Paris, France
Contact: Fabre, Prof.         
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil Recruiting
Strasbourg, France
Contact: Thaveau, Prof.         
Policlinico Sant' Orsola - Malpighi Recruiting
Bologna, Italy
Contact: Lovato, Dr.         
IRCCS Policlinico San Donato Recruiting
Milano, Italy
Contact: Santi Trimarchi, Prof.         
Ospedale San Raffaele - Milano Recruiting
Milano, Italy
Contact: Chiesa, Prof.         
Università di Perugia - Ospedale S.M. Della Misericordia Recruiting
Perugia, Italy
Principal Investigator: Fabio Verzini, Prof.         
Maastricht Universitair Medisch Centrum (MUMC) Recruiting
Maastricht, Netherlands
Contact: Schurink, Prof.         
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Heijmen, Dr.         
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke`s Hospital Recruiting
Cambridge, United Kingdom
Contact: Paul Hayes, Prof.         
Imperial College Healthcare NHS Trust - St Mary's Hospital Recruiting
London, United Kingdom
Contact: Colin Bicknell, Dr.         
Saint George's Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Ian Loftus, Prof.         
Sponsors and Collaborators
Medtronic Endovascular

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02625324     History of Changes
Other Study ID Numbers: 10219493DOC
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: January 2017

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