The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study

August 11, 2026 updated by: W.L.Gore & Associates
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GORE® VIABAHN® FORTEGRA Venous Stent
Device: GORE® VIABAHN® FORTEGRA Venous Stent
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary effectiveness as assessed by primary patency
Time Frame: 12 months
Rate of subjects with primary patency as confirmed by imaging and adverse events
12 months
Primary safety as assessed by SAEs
Time Frame: 30 days
Rate of subjects with freedom from device- or index procedure-related SAEs
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of subjects with primary patency as confirmed by imaging and adverse events
Time Frame: 36 months

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
36 months
Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment
Time Frame: 36 months
Freedom from permanent loss of blood flow through the device, regardless of reintervention
36 months
Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Time Frame: 36 months
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
36 months
Number of subjects with stent embolization as confirmed by adverse events and imaging
Time Frame: 12 months
Number of subjects with stent embolization
12 months
Number of subjects with device- or index procedure-related death as confirmed with adverse events
Time Frame: 30 days
Number of subjects with device- or index procedure-related death
30 days
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
Time Frame: 30 days
Number of subjects with clinically significant pulmonary embolism as confirmed via CTA
30 days
Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events
Time Frame: 30 days
Number of subjects with device- or index procedure-related vascular injury requiring surgical or endovascular intervention
30 days
Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events
Time Frame: 30 days
Number of subjects with device- or index procedure-related major bleeding events
30 days
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Time Frame: 36 months
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 36-month follow-up compared to baseline prior to treatment
36 months
Technical success
Time Frame: Index procedure (post-op day 0)
Number of subjects with successful delivery and deployment of the stent to the intended location
Index procedure (post-op day 0)
Lesion success
Time Frame: Index procedure (post-op day 0)
Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or contrast angiography
Index procedure (post-op day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erin Murphy, MD, Atrium Health Sanger Heart and Vascular Institute
  • Principal Investigator: Parag Patel, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VNS 25-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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