Evaluation of the Zilver® Vena™ Venous Stent (VIVO EU)

Cook Group

Status: Completed

Conditions: Iliofemoral Venous Outflow Obstruction

Treatments: Device: Zilver Vena Venous Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT01663051

10-018

Details and patient eligibility

About

This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by:
• CEAP 'C' ≥ 3, or
• VCSS pain score ≥ 2

Exclusion criteria

• < 18 years of age
• Pregnant or planning to become pregnant in the next 12 months
• Planned surgical or interventional procedures (except thrombolysis and thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or after the study procedure.
• Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter
• Previous stenting of the target vessel
• Iliofemoral venous segment unsuitable for treatment with available sizes of study devices

Trial design

35 participants in 1 patient group

Stent

Description:

Stent

Treatment:

Device: Zilver Vena Venous Stent