RECRUITING

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

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Conditions

Aortoiliac Occlusive Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Official Title

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

Quick Facts

Study Start:2025-05-30
Study Completion:2027-08-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06872905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
  2. 2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
  3. 3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
  4. 4. Age ≥18 years at the time of CERAB procedure.
  5. 5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
  1. 1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
  2. 2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
  3. 3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

Contacts and Locations

Study Contact

Jennifer Camoriano, BS
CONTACT
14805365820
jcamoria@wlgore.com
Chris Timberlake, BS
CONTACT
1-928-707-4974
ctimberl@wlgore.com

Principal Investigator

Leigh Ann O'Banion, M.D.
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Michele Antonello, M.D.
PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Padova

Study Locations (Sites)

University of California
Fresno, California, 93721
United States
Marshfield Hospital
Marshfield, Wisconsin, 54449
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

  • Leigh Ann O'Banion, M.D., PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Michele Antonello, M.D., PRINCIPAL_INVESTIGATOR, Azienda Ospedaliero-Universitaria di Padova

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2027-08-16

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2027-08-16

Terms related to this study

Additional Relevant MeSH Terms

  • Aortoiliac Occlusive Disease