The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

NCT04943172 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P061
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 29

Brief 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).

Conditions

Deep Venous Insufficiency (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• The primary safety endpoint is the composite of the following Major Adverse Events:

  Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, Pulmonary embolism in 75 patients. Rate of \>9% is expected

  30 days

Secondary Outcomes (1)

• Major Adverse Event rates

  3, 6, 12 months and annually thereafter through 5 years

Study Arms (1)

VenoValve

EXPERIMENTAL

Subjects who receive VenoValve implant

Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)

Interventions

Hancock-Jaffe bioprosthetic venous valve (VenoValve®) DEVICE

Surgical implantation of the VenoValve device

VenoValve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failure of at least 3 months of standard care including compression therapy, and in C6 patients, wound care,
• Axial deep reflux \>1000 msec. at the level of the popliteal vein
• Venous valvular incompetence from primary or secondary causes, e.g., post-thrombotic syndrome (PTS),
• CEAP score: C4b, C4c, C5, or C6,
• Diameter of native target vein ≥8 mm,
• Age ≥18 years,
• Ability to tolerate duplex ultrasound,
• Ability to ambulate without assistance,
• Able to attend scheduled post-treatment follow-up visits,
• BMI \<40,
• Willing and able to comply with all compulsory study procedures and provide informed consent prior to any study procedures being performed,
• Negative COVID-19 test within 6 days of index procedure or record of full vaccination for COVID-19,
• Female patients of childbearing potential must:
• have negative pregnancy test at the screening visit or within 7 days of the index procedure, whichever is later,
• not be breastfeeding or plan to breastfeed through completion of the study,

You may not qualify if:

• Presence of superficial reflux,
• Presence of untreated iliac/IVC obstruction greater than 50% in diameter reduction,
• Previously documented hypercoagulable condition that cannot be adequately treated with anticoagulation,
• Previous open surgical procedure in the ipsilateral deep venous system,
• Venous stent in the ipsilateral femoral or popliteal vein,
• Extensive infrainguinal obstruction of the venous system,
• DVT or pulmonary embolism within 30 days of the planned procedure,
• Active malignancy excepting non-melanoma skin cancer,
• Arterial insufficiency with measured ABI \<0.70
• Lymphedema not due to venous disease,
• Current or planned participation in another clinical trial within 30 days of treatment,
• Minor venous procedures (e.g., superficial vein procedures or venous stenting) within 6 weeks of screening,
• New York Heart Association Class III or greater,
• Fibromyalgia,
• Chronic narcotic usage,

Sponsors & Collaborators

• Hancock Jaffe Laboratiores, Inc: lead
• AXIOM Real Time Metrics: collaborator
• Syntactx: collaborator

Study Sites (29)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Pima Heart and Vascular

Tucson, Arizona, 85719, United States

Location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

Yale school of Medicine

New Haven, Connecticut, 06510, United States

Location

Coastal Vascular

Fort Walton Beach, Florida, 32547, United States

Location

Miami Vascular Specialists

Miami, Florida, 33176, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Kaleidahealth

Buffalo, New York, 14203, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Stony Brook Medicine

New York, New York, 11794, United States

Location

St. Peter's Vascular Associates

Troy, New York, 12180, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27516, United States

Location

TriHealth

Cincinnati, Ohio, 45220, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44132, United States

Location

Jobst Vascular Institute / Promedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Sentara

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Ulloa JH, Glickman M. One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency. Vasc Endovascular Surg. 2022 Apr;56(3):277-283. doi: 10.1177/15385744211073730. Epub 2022 Feb 7.

  PMID: 35129407 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Glickman, MD

  Hancock Jaffe Laboratories, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: August 27, 2021
• Primary Completion: October 18, 2024
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)