Trial Search Results

Valiant Evo US Clinical Trial

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medtronic Endovascular

Stanford Investigator(s):

Intervention(s):

  • Device: Valiant Evo Thoracic Stent Graft

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Steven Cavella
Recruiting