Clinical trial for Venous Thromboses
Official title The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
ClinicalTrials.gov ID: NCT07538609
What this study is testing
- What it's testing
- This study is testing whether the stent works safely and helps vein problems in real‑world use.
- Who it's for
- You may be able to join if you have a vein condition such as a clot, blockage, or ulcer.
- What's involved
- You will have the stent placed in your vein by a doctor. You will return for follow‑up visits to check how you are doing.
- Time commitment
- The study follows you for several months with a few clinic visits.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Preoperative
- Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an...
- 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
You likely can't join if
- Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
See the full eligibility criteria
- Preoperative
- 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
- 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
- Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
The study team makes the final eligibility decision.
Where it is enrolling
- Darien, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Darien, Connecticut, United States; Washington D.C., District of Columbia, United States; Dallas, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.