VIVO Clinical Study
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ClinicalTrials.gov Identifier: NCT01970007 |
Recruitment Status :
Completed
First Posted : October 25, 2013
Last Update Posted : January 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein | Device: Zilver Vena Venous Stent | Not Applicable |
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 |
Study Start Date : | December 12, 2013 |
Actual Primary Completion Date : | November 20, 2017 |
Actual Study Completion Date : | November 12, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Zilver Vena Venous Stent |
Device: Zilver Vena Venous Stent
stenting
Other Name: venous stent |
- Freedom from major adverse events [ Time Frame: 30 days ]
- Primary patency [ Time Frame: 12 months ]
- Change in VCSS [ Time Frame: 1 month ]
- Change in VCSS [ Time Frame: 12 months ]

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

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

Principal Investigator: | Anthony J. Comerota, MD, FACS, FACC | Jobst Vascular Institute | |
Principal Investigator: | Lawrence "Rusty" Hofmann, MD | Stanford University |
Responsible Party: | Cook Research Incorporated |
ClinicalTrials.gov Identifier: | NCT01970007 |
Other Study ID Numbers: |
11-010 |
First Posted: | October 25, 2013 Key Record Dates |
Last Update Posted: | January 22, 2020 |
Last Verified: | January 2020 |
venous outflow obstruction iliofemoral vein |