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

February 13, 2025 updated by: Hancock Jaffe Laboratiores, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary safety endpoint is the composite of the following Major Adverse Events:
Time Frame: 30 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Adverse Event rates
Time Frame: 3, 6, 12 months and annually thereafter through 5 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hancock Jaffe Laboratiores, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syntactx
AXIOM Real Time Metrics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marc Glickman, MD, Hancock Jaffe Laboratories, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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