Vascular Stent for Deep Vein Thrombosis

Palo Alto (17 mi)

Kush R. Desai, MD | Northwestern Medicine

Dr. Kathleen Gibson, MD - Bellevue, WA ...

Overseen byKush Desai, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: W.L.Gore & Associates

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.

Eligibility Criteria

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.

Inclusion Criteria

My vein condition is severe or causes me significant pain.

I plan to use only the GORE® VIAFORT Vascular Stent for my treatment.

My blood vessels near the lesion are healthy and don't need treatment.

I have a blocked vein in my leg that causes symptoms.

I am 18 years old or older.

My vein condition is only in one leg and plans are to place a stent there.

My veins are suitable for the medical device needed for treatment.

I have a blockage in one of my leg's main veins.

Exclusion Criteria

I have a genetic blood clotting disorder.

I have a serious lung clot confirmed by a CT scan causing symptoms like chest pain or difficulty breathing.

I have a clotting disorder and cannot or will not take blood thinners long-term.

I have a bleeding disorder that cannot be corrected, with specific blood cell count levels.

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.

My kidney function is very low or I am on dialysis.

My BMI is over 40.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: GORE® VIAFORT Vascular StentExperimental Treatment1 Intervention

GORE® VIAFORT Vascular Stent