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

The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Deep Venous Insufficiency (Diagnosis)
• Intervention / Treatment: Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Pima Heart and Vascular
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Florida
    • Fort Walton Beach, Florida, United States, 32547
      • Coastal Vascular
    • Miami, Florida, United States, 33176
      • Miami Vascular Specialists
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • Kaleidahealth
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10016
      • NYU Langone
    • New York, New York, United States, 11794
      • Stony Brook Medicine
    • Troy, New York, United States, 12180
      • St. Peter's Vascular Associates
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth
    • Cleveland, Ohio, United States, 44132
      • University Hospitals Cleveland Medical Center
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institute / Promedica Toledo Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Failure of at least 3 months of standard care including compression therapy, and in C6 patients, wound care,
2. Axial deep reflux >1000 msec. at the level of the popliteal vein
3. Venous valvular incompetence from primary or secondary causes, e.g., post-thrombotic syndrome (PTS),
4. CEAP score: C4b, C4c, C5, or C6,
5. Diameter of native target vein ≥8 mm,
6. Age ≥18 years,
7. Ability to tolerate duplex ultrasound,
8. Ability to ambulate without assistance,
9. Able to attend scheduled post-treatment follow-up visits,
10. BMI <40,
11. Willing and able to comply with all compulsory study procedures and provide informed consent prior to any study procedures being performed,
12. Negative COVID-19 test within 6 days of index procedure or record of full vaccination for COVID-19,

13. 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:

1. Presence of superficial reflux,
2. Presence of untreated iliac/IVC obstruction greater than 50% in diameter reduction,
3. Previously documented hypercoagulable condition that cannot be adequately treated with anticoagulation,
4. Previous open surgical procedure in the ipsilateral deep venous system,
5. Venous stent in the ipsilateral femoral or popliteal vein,
6. Extensive infrainguinal obstruction of the venous system,
7. DVT or pulmonary embolism within 30 days of the planned procedure,
8. Active malignancy excepting non-melanoma skin cancer,
9. Arterial insufficiency with measured ABI <0.70
10. Lymphedema not due to venous disease,
11. Current or planned participation in another clinical trial within 30 days of treatment,
12. Minor venous procedures (e.g., superficial vein procedures or venous stenting) within 6 weeks of screening,
13. New York Heart Association Class III or greater,
14. Fibromyalgia,
15. Chronic narcotic usage,
16. Positive COVID-19 test within the last 3 months.
17. Other medical conditions or comorbidities which, in the opinion of the investigator, would interfere with study compliance,
18. Contraindication to anticoagulation,
19. Stainless steel sensitivity/ porcine tissue sensitivity,
20. Active superficial thrombophlebitis,
21. Thrombocytosis with platelet count > 1 million/microliter,
22. Unwilling or unable to comply with post-operative anticoagulation regimen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hancock Jaffe Laboratiores, Inc
• Collaborators: Syntactx; AXIOM Real Time Metrics
• Investigators: Study Director: Marc Glickman, MD, Hancock Jaffe Laboratories, Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): October 18, 2024
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: P061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes