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Vascular Stent
Vascular Stent for Venous Obstruction
N/A
Recruiting
Led By Stephen Black, MD, FRCS (Ed), FEBVS
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.
Patient is at least 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study Summary
This trialtests the safety and effectiveness of a medical device for treating blockages in veins in adults.
Who is the study for?
Adults over 18 with symptomatic vein blockages in the legs, able to follow treatment and check-up plans, not pregnant or planning pregnancy within a year. Excludes those with severe kidney issues, recent surgeries, significant blood clots in lungs, low hemoglobin levels, bleeding disorders, current participation in conflicting studies, major leg amputations, certain genetic conditions or drug sensitivities.Check my eligibility
What is being tested?
The trial is testing the GORE® VIAFORT Vascular Stent's performance and safety for treating adults with blocked veins in their lower body. It's a forward-looking study across multiple centers where all participants receive the stent without being compared to another group.See study design
What are the potential side effects?
While specific side effects are not listed here for the GORE® VIAFORT Vascular Stent procedure itself; generally such interventions may include pain at insertion site, infection risk around stented area and potential clotting or migration of the stent.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vein condition is severe or causes me significant pain.
Select...
I am 18 years old or older.
Select...
I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of efficacy and safety events
Secondary outcome measures
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 moreTrial 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
95 Previous Clinical Trials
28,216 Total Patients Enrolled
1 Trials studying Venous Stenosis
165 Patients Enrolled for Venous Stenosis
Stephen Black, MD, FRCS (Ed), FEBVSPrincipal InvestigatorGuy's and St Thomas' NHS Foundation Trust
Kush Desai, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
193 Total Patients Enrolled
1 Trials studying Venous Stenosis
165 Patients Enrolled for Venous Stenosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have or might have an infection.My vein condition is severe or causes me significant pain.I am 18 years old or older.You have used illegal drugs through a needle in the past year.My BMI is over 40.I am willing and able to follow all treatment and check-up plans.You have had stents or grafts placed in the blood vessels being studied.I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.I have severe artery problems in my legs.My kidney function is very low or I am on dialysis.I am currently receiving or planning to start cancer treatment.I am scheduled for surgery around the time of the study procedure.I can walk, even if I need a cane or walker.I am not pregnant, breastfeeding, planning to become pregnant, or unwilling to use birth control for the next 12 months.I currently have a serious lung blood clot.Your hemoglobin level is less than 9 grams per deciliter and has not been treated.I have a bleeding disorder that cannot be corrected.I have had a major part of my leg amputated.I have a genetic blood clotting disorder.My veins near the target area are healthy enough for treatment.You have a history of a condition that makes your blood clot more easily and you don't want to take medication to prevent blood clots for a long time.
Research Study Groups:
This trial has the following groups:- Group 1: GORE® VIAFORT Vascular Stent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research effort still open?
"According to the information on clinicaltrials.gov, this medical trial is currently recruiting participants. The study was initially announced on October 25th of 2022 and its details were last revised December 1st of that same year."
Answered by AI
How many participants can enlist in this research program?
"Affirmative. According to the data on clinicaltrials.gov, this particular medical trial is in an active recruitment phase which started on October 25th 2022 and was last updated December 1st 2022. A total of 111 patients are required from one sole centre for participation."
Answered by AI
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