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

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).

Study Overview

Study Details

Study overview

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).

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

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

Condition
Aortoiliac Occlusive Disease
Intervention / Treatment

-

Contacts and Locations

Fresno

University of California, Fresno, California, United States, 93721

Marshfield

Marshfield Hospital, Marshfield, Wisconsin, United States, 54449

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
  • 2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
  • 3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
  • 4. Age ≥18 years at the time of CERAB procedure.
  • 5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
  • 1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
  • 2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
  • 3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-08-16