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NCT02655887 · ClinicalTrials.gov registry record · NA
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
A NA study of Peripheral Vascular Disease and Venous Disease, sponsored by C. R. Bard.
- Completed
- Registry status
- NA
- Development phase
- 170
- Enrollment target
- 20
- Study locations
NCT02655887: Completed NA study of Peripheral Vascular Disease and Venous Disease, sponsored by C. R. Bard.
NCT02655887 is a NA study of Peripheral Vascular Disease and Venous Disease that has completed, run by C. R. Bard. The registered enrollment target is 170 participants, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02655887, a NA study of Peripheral Vascular Disease and Venous Disease, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
- 20
- Study locations
Study Summary
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
Primary Outcome
Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis \> 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Conditions Studied
Interventions
- DEVICE VENOVO™ Venous Stent
Study Locations (20)
Other
- Uniklinik RWTH - Aachen
- Klinikum Arnberg - Arnsberg
- Universitaets-Herrzentrum Freiburg-Bad Krozingen - Bad Krozingen
- University Hospital Galway - Galway
- MUMC Maastricht - Maastricht
- Fundacion de investigacion HM Hospitales - Madrid
Connecticut
- Vascular Breakthroughs, LLC - Darien
- Yale University - New Haven
Virginia
- Centra Health, Inc., dba Stroobants Cardiovascular Center - Lynchburg
- Sentara Medical Group - Virginia Beach
Iowa
- Midwest Cardiovascular Research Foundation - Davenport
Michigan
- Metro Health Hospital - Wyoming
Missouri
- Cox Medical Centers - Springfield
New York
- Mount Sinai Medical Center - New York
North Carolina
- North Carolina Heart and Vascular - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2016-06-15 |
| Est. Completion | 2020-10-30 |
| Phase | NA |
What the finished NCT02655887 record still lists
NCT02655887 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 25 other Peripheral Vascular Disease trials with a reported enrollment target (38% lower).
The record links to 4 conditions, with Peripheral Vascular Disease appearing as the primary indexed condition, and to 1 intervention - of which VENOVO™ Venous Stent is the first listed.
NCT02655887 names 20 study sites across 13 states, led by Other, Connecticut, Virginia.
Frequently Asked Questions
What is clinical trial NCT02655887 about?
NCT02655887 is a clinical study titled "BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease". The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
What is the current status of trial NCT02655887?
This trial is currently completed. It is a NA study. The enrollment target is 170 participants. The study started on 2016-06-15. Estimated completion is 2020-10-30.
What conditions does trial NCT02655887 study?
This clinical trial studies the following conditions: Peripheral Vascular Disease, Venous Disease, May-Thurner Syndrome, Iliofemoral Occlusive Disease.
What interventions are being tested in trial NCT02655887?
The interventions under investigation include: VENOVO™ Venous Stent (DEVICE).
Who is sponsoring clinical trial NCT02655887?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02655887 being conducted?
This trial has 20 study locations across Connecticut, Iowa, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02655887's enrollment target sits among peer trials
170 10th of 25 higher than 16 of 25 other Peripheral Vascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Vascular Disease 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.
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