VIVO Clinical Study

N/ACompletedNCT01970007

Cook Research Incorporated243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

243

Conditions

Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein

Interventions

Zilver Vena Venous Self-Expanding StentDEVICE

stenting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

Number of Participants With 30-day Freedom From Major Adverse Events

Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.

Time frame: 30 days

The Rate of Participants With Primary Quantitative Patency at 12 Months

Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) \> 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.

Time frame: 12 months

Secondary Outcomes

Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month

Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30. Mean change = (1-month score - Baseline Score)

Time frame: Baseline and 1 month

Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Arrowhead Hospital

Glendale, Arizona, United States

Littleton Adventist Hospital

Littleton, Colorado, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

Southern Connecticut Vascular Center - Norwalk Hospital

Norwalk, Connecticut, United States

Christiana Care Health Systems

Newark, Delaware, United States

Florida Pepin Heart Institute

Tampa, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

St. Vincent Medical Group

Indianapolis, Indiana, United States

...and 20 more locations