IRB Study Number 22-1173
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Viafort is a prospective, non-randomized, multicenter, single-arm, clinical study. The Viafort Vascular Stent is for the treatment of unilateral symptomatic iliofemoral venous obstruction.
Inclusion Criteria
- Patient has adequate inflow to the target lesion(s), per investigator discretion, involving at least a patent femoral or deep femoral vein.
- Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.
- One of the following: Clinical severity class of CEAP 'C' classification ≥ 3 or rVCSS pain score ≥ 2.
- Patient must be ≥ 18 years of age.
Exclusion Criteria
- Patient has DVT in the target areas with symptom onset date greater than 14 days but ≤ 90 days prior to treatment.
- Patient has clinically significant pulmonary embolism at the time of enrollment.
- Patient has known uncorrectable bleeding diathesis or active coagulopathy.
- Patient has impaired renal function or is currently on dialysis.
- Patient has uncorrected hemoglobin of <9 g/dL.
- Patient has significant peripheral arterial disease.
