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NCT04943172 · ClinicalTrials.gov registry record · NA
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study
A NA study of Deep Venous Insufficiency (Diagnosis), sponsored by Hancock Jaffe Laboratiores.
- Active
- Registry status
- NA
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04943172: Active NA study of Deep Venous Insufficiency (Diagnosis), sponsored by Hancock Jaffe Laboratiores.
NCT04943172 is a NA study of Deep Venous Insufficiency (Diagnosis) that is active but no longer recruiting, run by Hancock Jaffe Laboratiores. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04943172, a NA study of Deep Venous Insufficiency (Diagnosis), is active but no longer recruiting, sponsored by Hancock Jaffe Laboratiores.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
Primary Outcome
Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, Pulmonary embolism in 75 patients. Rate of \>9% is expected
Conditions Studied
Interventions
- DEVICE Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
Study Locations (20)
New York
- Albany Medical Center - Albany
- Kaleidahealth - Buffalo
- NYU Langone - New York
- Mount Sinai Hospital - New York
- Stony Brook Medicine - New York
- St. Peter's Vascular Associates - Troy
Florida
- Coastal Vascular - Fort Walton Beach
- Miami Vascular Specialists - Miami
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Pima Heart and Vascular - Tucson
California
- Cedars-Sinai Medical Center - Beverly Hills
Connecticut
- Yale school of Medicine - New Haven
Illinois
- University of Chicago - Chicago
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2028-03 |
| Phase | NA |
What the registry record for NCT04943172 still lists
NCT04943172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Deep Venous Insufficiency (Diagnosis) appearing as the primary indexed condition, and to 1 intervention - of which Hancock-Jaffe bioprosthetic venous valve (VenoValve®) is the first listed.
NCT04943172 names 20 study sites across 14 states, led by New York, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT04943172 about?
NCT04943172 is a clinical study titled "The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study". A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
What is the current status of trial NCT04943172?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 75 participants. The study started on 2021-08-27. Estimated completion is 2028-03.
What conditions does trial NCT04943172 study?
This clinical trial studies the following conditions: Deep Venous Insufficiency (Diagnosis).
What interventions are being tested in trial NCT04943172?
The interventions under investigation include: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) (DEVICE).
Who is sponsoring clinical trial NCT04943172?
This trial is sponsored by Hancock Jaffe Laboratiores, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04943172 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04943172's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 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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