VIVO Clinical Study

Cook Group

Status: Completed

Conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein

Treatments: Device: Zilver Vena Venous Self-Expanding Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970007

11-010

Details and patient eligibility

About

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:

  • CEAP "C" ≥ 3, or
  • VCSS pain score ≥ 2

Key Exclusion Criteria:

• < 18 years of age;
• pregnant or planning to become pregnant in the next 12 months;
• planned surgical or interventional procedures of the target limb (except thrombolysis and/or 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 any time after the study procedure;
• planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 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;
• lesion with malignant obstruction;
• previous stenting of the target vessel;
• iliofemoral venous segment unsuitable for treatment with available sizes of study devices.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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243 participants in 1 patient group

Zilver Vena Venous Self-Expanding Stent

Experimental group

Treatment:

Device: Zilver Vena Venous Self-Expanding Stent