The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

Running, not enrolling · Not applicable

Conditions studied: Deep Venous Insufficiency (Diagnosis)

In brief

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).

Key facts

Study ID

NCT04943172

Run by

Hancock Jaffe Laboratiores, Inc

People needed

75

Starts

2021-08-27

Expected to finish

2028-03-01

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• agree to use a medically acceptable method of preventing conception from the screening visit 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,
• Positive COVID-19 test within the last 3 months.
• Other medical conditions or comorbidities which, in the opinion of the investigator, would interfere with study compliance,
• Contraindication to anticoagulation,
• Stainless steel sensitivity/ porcine tissue sensitivity,
• Active superficial thrombophlebitis,
• Thrombocytosis with platelet count > 1 million/microliter,
• Unwilling or unable to comply with post-operative anticoagulation regimen.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pima Heart and Vascular — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• Yale school of Medicine — New Haven, Connecticut, United States
• Coastal Vascular — Fort Walton Beach, Florida, United States
• Miami Vascular Specialists — Miami, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Englewood Health — Englewood, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• Kaleidahealth — Buffalo, New York, United States
• NYU Langone — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Stony Brook Medicine — New York, New York, United States
• St. Peter's Vascular Associates — Troy, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• TriHealth — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Jobst Vascular Institute / Promedica Toledo Hospital — Toledo, Ohio, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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