Recruiting

VBX Device

Sponsor:

W.L.Gore & Associates

Code:

NCT06872905

Conditions

Aortoiliac Occlusive Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Study Details

Brief summary:

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).

Conditions

Aortoiliac Occlusive Disease

Study ID

NCT06872905

Start date

May 30, 2025

Status verified date

Jul, 2026

Completion date

Aug 16, 2027

Anticipated

Primary completion date

Aug 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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) -

Exclusion Criteria:

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.

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Study Design

Enrollment

158 participants

Anticipated

Interventions and Outcome Measures

Arms

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis

Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Interventions

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Primary outcome measure

  • Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) [ Time Frame: 1-Year ]
  • Primary Safety Endpoint: 30-day Morbidity (hypothesis testing) [ Time Frame: 30-Day ]

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

Fresno, California, United States, 93721

Principal Investigator:

Leigh Ann O'Banion, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Fahad Shuja, MBBS

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Principal Investigator:

Laurel Hastings, MD

Rutgers

Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator:

William Beckerman, MD

Research Foundation SUNY Buffalo

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Linda Harris, MD

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ajit Rao, MD

Research Foundation at SUNY Syracuse

Recruiting

Syracuse, New York, United States, 13210

Principal Investigator:

Palma Shaw, MD

Atrium Health Sanger Heart & Vascular Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Hector Crespo-Soto, MD

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Kyongjune Lee, MD

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Principal Investigator:

Evan Ryer, MD

University Of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Grace WANG, MD

Sanford Clinical Vascular Associates

Recruiting

Sioux Falls, South Dakota, United States, 57105

Principal Investigator:

Anand Dayama, MD

Wellmont Holston Valley Medical Center

Recruiting

Kingsport, Tennessee, United States, 37760

Principal Investigator:

Ryan Cronin, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Daniiel Clair, MD

The University of Texas Austin

Recruiting

Austin, Texas, United States, 78712

Principal Investigator:

Meryl Logan, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Behzad Farivar, MD

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24016

Principal Investigator:

Esmaeel Dadashzadeh, MD

Marshfield Hospital

Recruiting

Marshfield, Wisconsin, United States, 54449

Principal Investigator:

Shameem Kunhammed, MD

Marshfield Medical Center - Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Principal Investigator:

Shameem Kunhammed, MD

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-07-07.