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Completed

NCT Number: NCT01970007

VIVO Clinical Study

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.

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Key information

Conditions

Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Wan Fang Hospital, Taipei, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zilver Vena Venous Self-Expanding Stent

Device

stenting

Other names: venous stent

Primary outcomes

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

    Time frame: 30 days

    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.

  2. The Rate of Participants With Primary Quantitative Patency at 12 Months

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline and 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)

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

    Time frame: Baseline and 12 months

    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 = (12-month score - Baseline Score)

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Oct 25, 2013
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.