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VIVO Clinical Study

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ClinicalTrials.gov Identifier: NCT01970007
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein Device: Zilver Vena Venous Self-Expanding Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
Actual Study Start Date : December 13, 2013
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2019

Arm Intervention/treatment
Experimental: Zilver Vena Venous Self-Expanding Stent Device: Zilver Vena Venous Self-Expanding Stent
stenting
Other Name: venous stent




Primary Outcome Measures :
  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 Outcome Measures :
  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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970007


Locations
Show Show 30 study locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Anthony J. Comerota, MD, FACS, FACC Inova Vascular
Principal Investigator: Lawrence "Rusty" Hofmann, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Cook Group Incorporated ( Cook Research Incorporated ):
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT01970007    
Other Study ID Numbers: 11-010
First Posted: October 25, 2013    Key Record Dates
Results First Posted: April 8, 2021
Last Update Posted: April 8, 2021
Last Verified: March 2021
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
venous
outflow obstruction
iliofemoral vein