N/A
N=243
VIVO Clinical Study
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Bottom Line
View on ClinicalTrials.gov: NCT01970007 ↗Enrolled (actual)
243
Serious AEs
45.7%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With 30-day Freedom From Major Adverse Events — 232 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zilver Vena Venous Self-Expanding Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Research Incorporated
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 30-day Freedom From Major Adverse Events |
232 | <0.0001 sig |
| PRIMARY The Rate of Participants With Primary Quantitative Patency at 12 Months |
89.9 | <0.0001 sig |
| SECONDARY Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month |
8.0; -3.0 | <0.0001 sig |
| SECONDARY Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months |
8.0; -4.2 | <0.0001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01970007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.