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NCT01970007 · ClinicalTrials.gov registry record · NA
VIVO Clinical Study
A NA study of Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein, sponsored by Cook Research Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 243
- Enrollment target
- 20
- Study locations
NCT01970007: Completed NA study of Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein, sponsored by Cook Research Incorporated.
NCT01970007 is a NA study of Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein that has completed, run by Cook Research Incorporated. The registered enrollment target is 243 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970007, a NA study of Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein, has completed, sponsored by Cook Research Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 243 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Zilver Vena Venous Self-Expanding Stent
Study Locations (20)
Connecticut
- Yale-New Haven Hospital - New Haven
- Southern Connecticut Vascular Center - Norwalk Hospital - Norwalk
Indiana
- Methodist Hospital of Indiana - Indianapolis
- St. Vincent Medical Group - Indianapolis
Missouri
- Barnes Jewish Hospital Plaza - St Louis
- Mercy Hospital - St Louis
Alabama
- University of Alabama Birmingham Hospital - Birmingham
Arizona
- Arrowhead Hospital - Glendale
Colorado
- Littleton Adventist Hospital - Littleton
Delaware
- Christiana Care Health Systems - Newark
Florida
- Florida Pepin Heart Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2013-12-13 |
| Est. Completion | 2019-11-20 |
| Phase | NA |
What the finished NCT01970007 record still lists
NCT01970007 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein appearing as the primary indexed condition, and to 1 intervention - of which Zilver Vena Venous Self-Expanding Stent is the first listed.
NCT01970007 names 20 study sites across 17 states, led by Connecticut, Indiana, Missouri.
Frequently Asked Questions
What is clinical trial NCT01970007 about?
NCT01970007 is a clinical study titled "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.
What is the current status of trial NCT01970007?
This trial is currently completed. It is a NA study. The enrollment target is 243 participants. The study started on 2013-12-13. Estimated completion is 2019-11-20.
What conditions does trial NCT01970007 study?
This clinical trial studies the following conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein.
What interventions are being tested in trial NCT01970007?
The interventions under investigation include: Zilver Vena Venous Self-Expanding Stent (DEVICE).
Who is sponsoring clinical trial NCT01970007?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01970007 being conducted?
This trial has 20 study locations across Alabama, Arizona, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01970007's enrollment target sits among peer trials
243 438th of 2000 higher than 1,562 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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