Aortoiliac Occlusive DiseaseNCT06872905
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
An observational study of Aortoiliac Occlusive Disease, run by W.L.Gore & Associates at 27 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortoiliac Occlusive Disease
- What is being tested?
- GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
- Type of treatment
- Medical device
- How many people
- 158 participants
- Where
- 27 sitesin 5 countries
- Study dates
- 30 May 2025to 16 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population. Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia. According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t
Who may be able to join
- Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
- Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
- Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
- Age ≥18 years at the time of CERAB procedure.
- Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
Who cannot join
- Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
- Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
- Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
- -
Trial locations and contacts
27 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 5 countries
United States21 sites, 20 recruiting
- Recruiting
The University of Texas Austin
Austin, Texas, 78712
Andrea Stapper
Meryl Logan, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Benjamin Pearce, M.D., 205-934-2006, bjpearce@uabmc.edu
Rebecca St. John, (205) 369-0363, rstjohn@uabmc.edu
- Recruiting
Research Foundation SUNY Buffalo
Buffalo, New York, 14203
Dawn Holler
Linda Harris, MD
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Jonelle O'Shea
Laurel Hastings, MD
- Recruiting
Atrium Health Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28203
Houston Chapman
Hector Crespo-Soto, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Robin Kelly
Behzad Farivar, MD
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Subhashish Das
Kyongjune Lee, MD
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Rebecca Mack
Evan Ryer, MD
- Recruiting
University of California
Fresno, California, 93721
Jessica Gallegos
Leigh Ann O'Banion, MD
- Recruiting
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37760
Ashley Bowen
Ryan Cronin, MD
- Recruiting
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, 54449
Angela Varsho
Shameem Kunhammed, MD
- Completed
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Rutgers
New Brunswick, New Jersey, 08901
Marie Macor
William Beckerman, MD
- Recruiting
Mount Sinai Medical Center
New York, New York, 10029
Bridget Coyle
Ajit Rao, MD
- Recruiting
Integris Health Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Jones P Thomas, M.D., 405-951-4345, Jones.thomas@integrishealth.org
Natalie VanBuskirk, natalie.vanbuskirk@integrishealth.org
- Recruiting
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Carolina Reyes
Grace WANG, MD
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24016
Yili Zhong
Esmaeel Dadashzadeh, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Samantha Knight
Fahad Shuja, MBBS
- Recruiting
Sanford Clinical Vascular Associates
Sioux Falls, South Dakota, 57105
Karla Reily
Anand Dayama, MD
- Recruiting
Research Foundation at SUNY Syracuse
Syracuse, New York, 13210
Maria Walker
Palma Shaw, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Charles Briggs, M.D., 813-505-4787, cbriggs@usf.edu
Beth Montera, 1-813-844-7948, bmontera@usf.edu
Italy2 sites, 2 recruiting
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Padova
Padova, 35131
Michele Antonello, M.D., +39 0498218736, michele.antonello.1@unipd.it
- Recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Gabriele Piffaretti
Gabriel Piffaretti, MD
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC Research BV
Amsterdam, 1105
Rutger Lely
Rutger Lely, MD
- Recruiting
Franciscus
Rotterdam, 3045 PM
Jerome van Brussel
Jerome van Brussel, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
Elisabeth Cruces Fuentes
Elisabeth Cruces Fuentes, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Greater Glasgow Health Board
Glasgow, G12 OXH
Martin Hennessy
Martin Hennessy, MD
About this study
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).
Read the detailed description
A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.
- Conditions
- Aortoiliac Occlusive Disease
- Being tested
- GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)Device
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
| Study group | Role | What they receive |
|---|---|---|
| GORE VIABAHN® VBX Balloon Expandable Endoprosthesis | Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure. Receives: Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
Proportion of patients maintaining primary patency at 1 Year
Measured: 1-Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
Measured: 30-Day
Secondary outcomes (8)
Technical Success
Proportion of patients with technical success
Measured: At index procedure
Mortality
Proportion of patients with all cause death
Measured: 30-Day
Device Integrity
Proportion of patients achieving Primary Patency
Measured: 1 year
Primary assisted patency
Proportion of patients achieving Primary Assisted patency
Measured: 1 year
Secondary patency
Proportion of patients achieving Secondary Patency
Measured: 1 year
Freedom from Target Lesion Revascularization
Proportion of patients achieving freedom from Target Lesion Revascularization
Measured: 1 year
Survival
Proportion of patients survival
Measured: 1 Year
Freedom from Clinically-Driven Target Lesion Revascularization
Proportion of patients achieving freedom from Clinically-Driven Target Revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start30 May 2025
- Primary completion16 Aug 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortoiliac Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leigh Ann O'Banion, M.D., Principal investigator, University of California, San FranciscoMichele Antonello, M.D., Principal investigator, Azienda Ospedaliero-Universitaria di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872905
- Sponsor's protocol ID
- VBX 24-03
- Status last verified
- Nov 2026
- First submitted
- 24 Feb 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06872905
- Acronym / sponsor ID
- VBX 24-03
- Conditions
- Aortoiliac Occlusive Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 16 Aug 2027 (estimated)
- Study completion
- 16 Aug 2027 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE VIABAHN® VBX Balloon Expandable Endoprosthesis | – | Device: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As described in the background section, patients with aortoiliac occlusive disease are treated with various surgical and endovascular therapies to improve arterial blood flow to the lower extremity. This study will retrospectively evaluate a population of patients that have had covered endovascular reconstruction of the aortic bifurcation (CERAB) with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. The study has been designed with standard eligibility criteria to evaluate the safety and effectiveness of the VBX Device when used in a CERAB for an aortoiliac occlusive disease patient population. Considering the nature of aortoiliac occlusive disease, elderly patients (≥ 65 years old) can represent a significant number of patients enrolled in this study. This population can include patients with cognitive disorder or severe dementia. According to EU regulation, elderly patients are considered vulnerable population. However, considering the retrospective nature of the study design, t
Key inclusion criteria (5 listed)
- Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
- Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
- Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
- Age ≥18 years at the time of CERAB procedure.
- Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
Key exclusion criteria (4 listed)
- Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
- Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
- Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | GORE VIABAHN® VBX Balloon Expandable Endoprosthesis |
Primary outcome
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
Time frame: 1-Year
Proportion of patients maintaining primary patency at 1 Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
Time frame: 30-Day
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
8 secondary outcomes
Technical Success
Time frame: At index procedure
Mortality
Time frame: 30-Day
Device Integrity
Time frame: 1 year
Primary assisted patency
Time frame: 1 year
Secondary patency
Time frame: 1 year
Freedom from Target Lesion Revascularization
Time frame: 1 year
Survival
Time frame: 1 Year
Freedom from Clinically-Driven Target Lesion Revascularization
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leigh Ann O'Banion, M.D. principal investigator
University of California, San Francisco
Michele Antonello, M.D. principal investigator
Azienda Ospedaliero-Universitaria di Padova
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortoiliac Occlusive Disease, run by W.L.Gore & Associates at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Italy, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Camoriano, BS (14805365820, jcamoria@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing) (time frame: 1-Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.