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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250017 / PAS002 |
| Date Original Protocol Accepted |
04/07/2026
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| Date Current Protocol Accepted |
04/07/2026
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| Study Name |
The GORE VIABAHN FORTEGRA Venous Stent New Enrollment Study
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| Device Name |
GORE® VIABAHN® FORTEGRA Venous Stent
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| Clinical Trial Number(s) |
NCT05409976 NCT05489588
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, multicenter, single-arm, post-market clinical study. To evaluate the Gore Viabahn Fortegra Venous Stent in real world use.
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| Study Population |
Adult patients (at least 18 years of age) intended to receive the Gore Viabahn Fortegra Venous Stent in endovascular treatment. Only patients who meet all the inclusion criteria and none of the exclusion criteria will be implanted. Significant Inclusion Criteria Preoperative
- Presence of lesion expected to necessitate treatment with the Gore Viabahn Fortegra Venous Stent. Intraoperative
- Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub-investigator discretion.
Significant Exclusion Criteria Intraoperative Patient is contraindicated for treatment with the Gore Viabahn Fortegra Venous Stent according to the IFU. Intent to Treat population: All subjects who had a study device introduced into the vasculature. Per Protocol population: All subjects who had a study device introduced into the vasculature and were not determined to be ineligible for the study.
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| Sample Size |
Number of subjects: 150 subjects with the Gore Viabahn Fortegra device introduced into the vasculature, with a limit of 30 treated subjects per site Assumptions for sample size estimation: A sample size of 150 subjects with a study device introduced into the vasculature will be used to ensure broad representation of device usage. Number of sites: 20 sites up to a maximum of 35 sites will be enrolled Sites location: United States
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| Key Study Endpoints |
Primary Effectiveness
- Primary patency through 12 months Primary Safety
- Device Freedom from device- or index procedure-related SAEs through 30 days Secondary Endpoints
- Primary patency through 36 months
- Secondary patency through 36 months
- Clinically Freedom from clinically driven target lesion revascularization through 36 months
- Stent embolization through 12-month follow-up
- Device- or index procedure-related death through 30 days
- Clinically significant pulmonary embolism through 30 days
- Device- or index procedure-related vascular injury through 30 days requiring surgical or endovascular intervention
- Device- or index procedure-related major bleeding events through 30 days
- Change in EQ-5D-5L Measurement through 36-month follow-up compared to baseline prior to treatment
- Technical success
- Lesion success Additional assessment at 1, 6, 12, 24 and 36 months:
- Adverse events
- Concomitant medications
- rVCSS and Villalta (applicable only to subjects intended to be treated in the IVC or iliofemoral veins)
- Imaging of lesions /stents
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| Follow-up Visits and Length of Follow-up |
Dischage,1, 6-, 12-, 24-, and 36 months post treatment Subjects Lost to follow-up A subject is considered lost to follow-up after 2 consecutive follow-up visits, and 3 documented attempts have been made by the investigator or designee to contact the subject or next of kin. One of the three documented attempts must include a certified letter.
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