Trial Search Results

Zenith® p-Branch® Endovascular Graft Pivotal Study

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Cook Research Incorporated

Stanford Investigator(s):

Intervention(s):

  • Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter

   - Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year

   - Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
   diameter that is deemed to be at risk for rupture based upon physician interpretation

Exclusion Criteria:

   - Age <18 years

   - Life expectancy <2 years

   - Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

   - Inability or refusal to give informed consent by the patient or a legally authorized
   representative

   - Unwilling or unable to comply with the follow-up schedule

   - Simultaneously participating in another investigative device or drug study. (The
   patient must have completed the primary endpoint of any previous study at least 30
   days prior to enrollment in this study.)

   - Additional medical restrictions as specified in the Clinical Investigation Plan

   - Additional anatomical restrictions as specified in the Clinical Investigation Plan

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
Recruiting