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Vascular Stent

Vascular Stent for Deep Vein Thrombosis

N/A
Waitlist Available
Led By Kush Desai, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2
Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent
Must not have
Patient has known homozygous inherited coagulation defect or Protein C/S deficiency
Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial evaluates the safety and effectiveness of a stent to treat blocked veins in the legs.

Who is the study for?
This trial is for adults with symptomatic vein blockages in the leg who haven't had previous stenting or grafts, don't have significant artery disease, recent major amputations, or certain blood conditions. They must be able to receive a GORE® VIAFORT Vascular Stent and follow treatment plans including medications.
What is being tested?
The study tests the GORE® VIAFORT Vascular Stent's performance and safety in treating venous obstructions in the leg. It's a single-arm study where all participants receive the stent to see how well it works and what risks are involved.
What are the potential side effects?
Potential side effects may include pain at the insertion site, bleeding, infection risk from surgery, allergic reactions to materials or medications used during procedure (like contrast agents), and possible clotting issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My vein condition is severe or causes me significant pain.
Select...
I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.
Select...
My blood vessels near the lesion are healthy and don't need treatment.
Select...
I have a blocked vein in my leg that causes symptoms.
Select...
I am 18 years old or older.
Select...
My vein condition is only in one leg and plans are to place a stent there.
Select...
My veins are suitable for the medical device needed for treatment.
Select...
I have a blockage in one of my leg's main veins.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a genetic blood clotting disorder.
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I have a serious lung clot confirmed by a CT scan causing symptoms like chest pain or difficulty breathing.
Select...
I have a clotting disorder and cannot or will not take blood thinners long-term.
Select...
I have a bleeding disorder that cannot be corrected, with specific blood cell count levels.
Select...
I have severe blockages in my arteries.
Select...
I have had or need surgery on the deep veins in my limb.
Select...
I have had a major amputation above the ankle on the affected leg.
Select...
My kidney function is very low or I am on dialysis.
Select...
My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of safety events
Primary efficacy as assessed by primary patency
Secondary study objectives
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Lesion success
Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GORE® VIAFORT Vascular StentExperimental Treatment1 Intervention
GORE® VIAFORT Vascular Stent

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,624 Total Patients Enrolled
Kush Desai, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
139 Total Patients Enrolled
Kathleen Gibson, MDPrincipal InvestigatorLake Washington Vascular Surgeons
2 Previous Clinical Trials
630 Total Patients Enrolled

Media Library

GORE® VIAFORT Vascular Stent (Vascular Stent) Clinical Trial Eligibility Overview. Trial Name: NCT05489588 — N/A
Post-Thrombotic Syndrome Research Study Groups: GORE® VIAFORT Vascular Stent
Post-Thrombotic Syndrome Clinical Trial 2023: GORE® VIAFORT Vascular Stent Highlights & Side Effects. Trial Name: NCT05489588 — N/A
GORE® VIAFORT Vascular Stent (Vascular Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05489588 — N/A
~21 spots leftby Apr 2025
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