Menu
Not yet recruiting NCT07538609

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

No phase Interventional Venous Thromboses Venous Disease Venous Leg Ulcer Venous Stasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GORE® VIABAHN® FORTEGRA Venous Stent.
Who it may be relevant to
Registry conditions: Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.

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.

Interventions

  • Device GORE® VIABAHN® FORTEGRA Venous Stent
    Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.

Primary outcome measures

  • Primary effectiveness as assessed by primary patency [Time frame: 12 months]
  • Primary safety as assessed by SAEs [Time frame: 30 days]
Secondary outcome measures (11)
  • Rate of subjects with primary patency as confirmed by imaging and adverse events [Time frame: 36 months]
  • Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment [Time frame: 36 months]
  • Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events [Time frame: 36 months]
  • Number of subjects with stent embolization as confirmed by adverse events and imaging [Time frame: 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 clinically significant pulmonary embolism as confirmed with imaging and adverse events [Time frame: 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 major bleeding events as confirmed with adverse events [Time frame: 30 days]
  • 5 Level EuroQol-5 Dimension (EQ-5D-5L) [Time frame: 36 months]
  • Technical success [Time frame: Index procedure (post-op day 0)]
  • Lesion success [Time frame: Index procedure (post-op day 0)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07538609 · VNS 25-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗