An interventional study of GORE® VIABAHN® FORTEGRA Venous Stent in Venous Thromboses, Venous Disease and Venous Leg Ulcer, sponsored by W.L.Gore & Associates. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
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.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 150 is close to the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preoperative Inclusion Criteria:
Intraoperative Inclusion Criteria:
Intraoperative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GORE® VIABAHN® FORTEGRA Venous Stent
Device: GORE® VIABAHN® FORTEGRA Venous Stent
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Primary effectiveness as assessed by primary patency
Rate of subjects with primary patency as confirmed by imaging and adverse events
Time frame: 12 months
Primary safety as assessed by SAEs
Rate of subjects with freedom from device- or index procedure-related SAEs
Time frame: 30 days
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
Time frame: 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
Time frame: 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
Time frame: 36 months
Number of subjects with stent embolization as confirmed by adverse events and imaging
Number of subjects with stent embolization
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 36 months
Technical success
Number of subjects with successful delivery and deployment of the stent to the intended location
Time frame: 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
Time frame: Index procedure (post-op day 0)
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for May 2029, 33 months after the start.
Of 117 interventional studies with no phase under Venous Thrombosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 56. This study's planned 33 months is close to that.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Aug 2026, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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