Peripheral Vascular DiseasesEXPANDNCT03720704
Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
An observational study of Peripheral Vascular Diseases, run by W.L.Gore & Associates at 11 sites in 5 countries.
Trial summary
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 18 Dec 2018to Jul 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry has been designed with broad eligibility criteria to capture real-world VBX Stent Graft use, in multiple pathologies and in conditions needing preservation of peripheral vessels.
Who may be able to join
- Age ≥ 18 years.
- Signed informed consent form
- Endovascular indication for treatment based on treating physician's best medical judgment.
- Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
- Willingness of the patient to adhere to standard of care follow-up requirements.
Who cannot join
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
- Pregnant or breast-feeding female at time of informed consent signature.
- Life expectancy < 12 months due to comorbidities.
- Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
- Use of the VBX Stent Graft is for the treatment of aortic coarctations.
- Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Italy4 sites
Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
Bologna
Fondazione Poliambulanza
Brescia
Azienda Ospedaliero-Universitaria di Padova
Padova
Ospedale di Circolo e Fondazione Macchi
Varese
Germany2 sites
University Hospital Heidelberg
Heidelberg
St. Franziskus Hospital
Münster
Netherlands2 sites
University Medical Center Groningen
Groningen
Erasmus Medical Center
Rotterdam
Spain2 sites
Hospital Universitario Central de Asturias (HUCA)
Oviedo
University Hospital of Santiago de Compostela
Santiago de Compostela
About this study
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
- Conditions
- Peripheral Vascular Diseases
- Being tested
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Keywords
- Lesion-exclusion, Visceral Perfusion, Luminal Reconstruction, Occlusive Disease
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE VIABAHN VBX Balloon Expandable EndoprosthesisDevice
GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. Receives: Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure.
Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
Measured: 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start18 Dec 2018
- Primary completion13 Apr 2022
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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
- Prospective
- Enrolment
- 280 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Gargiulo, MD, Principal investigator, Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720704
- Sponsor's protocol ID
- VBX 17-04
- Acronym
- EXPAND
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2018
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Usai MV, Gargiulo M, Haulon S, Tielliu I, Bockler D, Verhagen H, Fernandez AM, Austermann MJ. A three-year experience with the balloon expandable GORE VIABAHN VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND trial. J Vasc Surg. 2025 Feb;81(2):319-323.e1. doi: 10.1016/j.jvs.2024.10.002. Epub 2024 Oct 9.
PubMed 39389214Usai MV, Gargiulo M, Haulon S, Tielliu I, Boeckler D, Verhagen H, Fernandez AM, Austermann MJ. One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11.
PubMed 37572891
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
- ClinicalTrials.gov ID
- NCT03720704
- Acronym / sponsor ID
- EXPAND / VBX 17-04
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Lesion-exclusion, Visceral Perfusion, Luminal Reconstruction, Occlusive Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 16 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | – | Device: GORE VIABAHN VBX Balloon Expandable EndoprosthesisThe GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry has been designed with broad eligibility criteria to capture real-world VBX Stent Graft use, in multiple pathologies and in conditions needing preservation of peripheral vessels.
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Signed informed consent form
- Endovascular indication for treatment based on treating physician's best medical judgment.
- Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
- Willingness of the patient to adhere to standard of care follow-up requirements.
Key exclusion criteria (7 listed)
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
- Pregnant or breast-feeding female at time of informed consent signature.
- Life expectancy < 12 months due to comorbidities.
- Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
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 EndoprosthesisGORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. | Device | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
Primary outcome
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
Time frame: 30 days post treatment
Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39389214Usai MV, Gargiulo M, Haulon S, Tielliu I, Bockler D, Verhagen H, Fernandez AM, Austermann MJ. A three-year experience with the balloon expandable GORE VIABAHN VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND trial. J Vasc Surg. 2025 Feb;81(2):319-323.e1. doi: 10.1016/j.jvs.2024.10.002. Epub 2024 Oct 9.
- Derived from this study: PubMed 37572891Usai MV, Gargiulo M, Haulon S, Tielliu I, Boeckler D, Verhagen H, Fernandez AM, Austermann MJ. One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11.
- 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. This study is not recruiting at the moment.
Mauro Gargiulo, MD principal investigator
Azienda Ospedaliera Policlinico Sant'Orsola Malpighi
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases, run by W.L.Gore & Associates at 11 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 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Germany, Netherlands, Spain, France. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events (time frame: 30 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720704, which also lists 2 linked publications.
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 14 Apr 2026.