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Vascular Stent
Vascular Stent for Deep Vein Thrombosis
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My vein condition is severe or causes me significant pain.
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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.
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I have a blocked vein in my leg that causes symptoms.
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I am 18 years old or older.
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My vein condition is only in one leg and plans are to place a stent there.
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My veins are suitable for the medical device needed for treatment.
Select...
I have a blockage in one of my leg's main veins.
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 safety events
Primary efficacy as assessed by primary patency
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
28,162 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic blood clotting disorder.My veins in the leg area are good enough for treatment, as decided by my doctor.I have a clotting disorder and cannot or will not take blood thinners long-term.I am willing and able to follow all treatment and check-up plans.I have had symptoms of a deep vein thrombosis between 14 and 90 days ago.I am currently receiving or planning to start cancer treatment.My vein condition is severe or causes me significant pain.I am scheduled for surgery within 30 days before or after the study procedure, not including pre-stenting.I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.I can walk, even if I need a cane or walker.I have a serious lung clot confirmed by a CT scan causing symptoms like chest pain or difficulty breathing.I have a bleeding disorder that cannot be corrected, with specific blood cell count levels.I am allergic or cannot take blood thinners, clot dissolvers, or iodine-based contrast.My target stent area is mostly clear of clots or has been successfully treated.My blood vessels near the lesion are healthy and don't need treatment.I have a blocked vein in my leg that causes symptoms.You have had previous stents or grafts in the blood vessels being studied.I have severe blockages in my arteries.I have had or need surgery on the deep veins in my limb.I have had a major amputation above the ankle on the affected leg.You are expected to live for at least 1 more year.My blood vessel can fit a specific type of stent, as confirmed by a special scan.You have used intravenous drugs in the past year.I am 18 years old or older.My vein condition is only in one leg and plans are to place a stent there.The lesion can be passed through with a guidewire.My kidney function is very low or I am on dialysis.My BMI is over 40.Your blood hemoglobin level is less than 9 grams per deciliter and has not been treated.My veins are suitable for the medical device needed for treatment.I may have an infection, but if it's chronic like HIV or hepatitis C, it's under control with treatment.I have a blockage in one of my leg's main veins.
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 this experiment currently recruiting participants?
"The clinical trial is actively recruiting according to the data hosted on clinicialtrials.gov, and was initially posted on March 1st 2023 with its last update occuring a week later."
Answered by AI
What is the aggregate of participants in this experiment?
"Affirmative. Clinicaltrials.gov's records verify that this clinical trial was initially posted on 3/1/2023 and is currently in search of suitable applicants. 165 participants will be accepted into the study which spans two different enrolment sites."
Answered by AI
What are the key aims of this experiment?
"Per the trial sponsor W.L.Gore & Associates, this experiment's primary efficacy will be measured over 12 months for stent embolization and 30 days for all other components. Technical success is defined as successful delivery of the stent to its intended location, lesion success as ≤50% residual stenosis at conclusion of index procedure, and primary patency being confirmed by imaging with adverse events also recorded."
Answered by AI
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