An observational study in Peripheral Vascular Diseases, sponsored by W.L.Gore & Associates. Active, not recruiting at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by W.L.Gore & Associates · Observational
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
1,019 studies on the registry are indexed under Peripheral Vascular Diseases; 124 are open to participants now.
This study's enrollment of 280 is above the median of 193 across 250 observational studies indexed under Peripheral Vascular Diseases.
Browse Peripheral Vascular Diseases studies →W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Device: GORE VIABAHN VBX Balloon Expandable Endoprosthesis
GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
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.
Time frame: 30 days post treatment
| Milestone | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Started | 280 |
| Completed | 210 |
| Not completed | 70 |
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.
| Participants | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events | 274 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | 49/280 (17.5%) | 153/280 (54.6%) | 15/280 (5.4%) |
| Event | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Stent-graft endoleak type IIGeneral disorders | 10/280 |
| PneumoniaInfections and infestations | 8/280 |
| Stent occlusionProduct Issues | 8/280 |
| SepsisInfections and infestations | 7/280 |
| Decompensation cardiacCardiac disorders | 5/280 |
| Stent-graft endoleak type ICGeneral disorders | 5/280 |
| AnemiaBlood and lymphatic system disorders | 4/280 |
| In-stent arterial restenosisGeneral disorders | 4/280 |
| Stent-graft endoleak type IAGeneral disorders | 4/280 |
| Stent-graft endoleak type IBGeneral disorders | 4/280 |
| Event | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Stent-graft endoleak type IIGeneral disorders | 15/280 |
| Age, Categorical(Participants) | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 68 |
| >=65 years | 212 |
| Age, Continuous(years) | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Mean | 70.7 ± 9.7 |
| Sex: Female, Male(Participants) | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Female | 75 |
| Male | 205 |
| Race and Ethnicity Not Collected(Participants) | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|
| Region of Enrollment(Participants) | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
|---|---|
| Netherlands | 60 |
| Italy | 77 |
| France | 8 |
| Germany | 92 |
| Spain | 43 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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W.L.Gore & Associates