Venous ThrombosesNCT07538609
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
A study testing GORE® VIABAHN® FORTEGRA Venous Stent in people with Venous Thromboses and Venous Disease, run by W.L.Gore & Associates.
Trial summary
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboses, Venous Disease, Venous Leg Ulcer
- What is being tested?
- GORE® VIABAHN® FORTEGRA Venous Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2026to May 2031
- Phase
- Interventional
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
Preoperative Inclusion Criteria:
- Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator.
- Patient is at least 18 years of age.
- Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
- Patient is able to provide informed consent themself.
Intraoperative Inclusion Criteria:
- Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
- Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
- Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.
- Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub- investigator discretion.
- Lesion can be traversed with a guidewire.
Intraoperative Exclusion Criteria:
- Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
Read the detailed description
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, Venous Ulcer, Venous Stenosis
- Being tested
- GORE® VIABAHN® FORTEGRA Venous Stent
- Keywords
- Vein Stent, VIAFORT, Venous Thrombosis, Venous Stenosis, Gore, Venous occlusion, VIABAHN FORTEGRA, FORTEGRA, Deep Venous Insufficiency, Deep venous, Venous Disease, DVT Treatment, Venous Stent, Venous insufficiency treatment options, Venous disease treatment options
- Medical subject headings
- Venous Thrombosis, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® FORTEGRA Venous StentDevice
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
| Study group | Role | What they receive |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent | Experimental | GORE® VIABAHN® FORTEGRA Venous Stent Receives: Device: GORE® VIABAHN® FORTEGRA Venous Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness as assessed by primary patency
Rate of subjects with primary patency as confirmed by imaging and adverse events
Measured: 12 months
Primary safety as assessed by SAEs
Rate of subjects with freedom from device- or index procedure-related SAEs
Measured: 30 days
Secondary outcomes (11)
Rate of subjects with primary patency as confirmed by imaging and adverse events
Rate of subjects with freedom from both:
- stent occlusion due to restenosis or thrombosis as confirmed with imaging, and
- clinically driven target lesion revascularization as confirmed with imaging and adverse events
Measured: 36 months
Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment
Freedom from permanent loss of blood flow through the device, regardless of reintervention
Measured: 36 months
Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Rate of subjects with Repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the study devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of symptoms present at baseline, or the onset of new symptoms related to the target lesion
Measured: 36 months
Number of subjects with stent embolization as confirmed by adverse events and imaging
Number of subjects with stent embolization
Measured: 12 months
Number of subjects with device- or index procedure-related death as confirmed with adverse events
Number of subjects with device- or index procedure-related death
Measured: 30 days
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
Number of subjects with clinically significant pulmonary embolism as confirmed via CTA
Measured: 30 days
Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events
Number of subjects with device- or index procedure-related vascular injury requiring surgical or endovascular intervention
Measured: 30 days
Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events
Number of subjects with device- or index procedure-related major bleeding events
Measured: 30 days
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 36-month follow-up compared to baseline prior to treatment
Measured: 36 months
Technical success
Number of subjects with successful delivery and deployment of the stent to the intended location
Measured: Index procedure (post-op day 0)
Lesion success
Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or contrast angiography
Measured: Index procedure (post-op day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start7 Oct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, multicenter, single-arm study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Murphy, MD, Principal investigator, Atrium Health Sanger Heart and Vascular InstituteParag Patel, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538609
- Sponsor's protocol ID
- VNS 25-06
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No