Trial Search Results

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Medtronic Endovascular

Stanford Investigator(s):

Intervention(s):

  • Device: Endurant Stent Graft System

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. Subject is ≥ 18 years old.

   2. Subject (or Subject's legal representative) understands and voluntarily has signed and
   dated an Informed Consent document approved by the Sponsor and by the Institutional
   Review Board.

   3. Subject is able and willing to comply with the protocol and undergo follow-up
   requirements.

   4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by
   American Society of Anesthesiologists (ASA) Physical Status Classification System I,
   II, III, or IV

   5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet
   protocol parameter

   6. Subject meets all the protocol anatomical criteria* as demonstrated on
   contrast-enhanced CT or MRA

   7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent
   Graft

   8. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral
   artery, or can tolerate a vascular conduit that allows introduction of the device.

   9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment
   of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

   1. Subject has a life expectancy < 1 year

   2. Subject is participating in another investigational drug or device study

   3. Subject requires emergent aneurysm treatment

   4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.

   5. Subject has a known hypersensitivity or contraindication to anticoagulants,
   antiplatelets, or contrast media, which is not amenable to pre-treatment.

   6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented
   clinical conditions that severely inhibit radiographic visualization of the aorta.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee
6507255227
Not Recruiting