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Trial record 16 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

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
Last Update Posted : April 17, 2018
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. 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 Phase
Aortic Aneurysm, Thoracic Device: Valiant Evo Thoracic Stent Graft System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : March 28, 2018
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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: 1 Month post-procedure ]

Other Outcome Measures:
  1. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 1 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings

  2. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 12 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings
    • Stent graft migration as compared to 1-month imaging
    • Aneurysm expansion > 5mm based on imaging findings relative to the 1-month visit

  3. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 24 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings
    • Stent graft migration as compared to 1-month imaging
    • Aneurysm expansion > 5mm based on imaging findings relative to the 1-month visit

  4. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 36 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings
    • Stent graft migration as compared to 1-month imaging
    • Aneurysm expansion > 5mm based on imaging findings relative to the 1-month visit

  5. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 48 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings
    • Stent graft migration as compared to 1-month imaging
    • Aneurysm expansion > 5mm based on imaging findings relative to the 1-month visit

  6. Safety and effectiveness outcome based on the proportion of subjects who experienced adverse events or had imaging findings [ Time Frame: 60 Month post-procedure ]

    Safety and effectiveness outcome based on the proportion of subjects who experienced:

    • All-cause mortality
    • Aneurysm-Related Mortality
    • MDEs
    • All AEs including:
    • MAEs
    • SAEs
    • Secondary procedures
    • Loss of stent graft patency based on imaging findings
    • Endoleaks based on imaging findings
    • Stent graft migration as compared to 1-month imaging
    • Aneurysm expansion > 5mm based on imaging findings relative to the 1-month visit



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 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


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Canada
Université Laval
Quebec, Canada
Denmark
Odense Universitetshospital
Odense, Denmark
France
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France
Centre Chirurgical Marie Lannelongue
Paris, France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Italy
Policlinico Sant' Orsola - Malpighi
Bologna, Italy
IRCCS Policlinico San Donato
Milano, Italy
Ospedale San Raffaele - Milano
Milano, Italy
Università di Perugia - Ospedale S.M. Della Misericordia
Perugia, 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

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: April 17, 2018
Last Verified: January 2018

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