The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

Study Overview
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Brief Summary
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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).

Detailed Description
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The purpose of this study is to evaluate the VenoValve System (Hancock Jaffe Laboratories) in human patients. The VenoValve System is designed for treatment of chronic deep venous insufficiency. The VenoValve System enables improvement in chronic lower extremity venous reflux through an open surgical technique. The objective of this study is to assess the safety and effectiveness of the VenoValve System for the treatment of patients with deep venous valvular insufficiency and the associated complications.

Official Title
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The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study

Conditions
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Deep Venous Insufficiency (Diagnosis)

Intervention / Treatment
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* Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VenoValve<br>Subjects who receive VenoValve implant | Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)<br>* Surgical implantation of the VenoValve device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event rates | Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, and Pulmonary Embolism | 3, 6, 12 months and annually thereafter through 5 years |