Deep Venous Insufficiency (Diagnosis)SAVVENCT04943172
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study
A study testing Hancock-Jaffe bioprosthetic venous valve (VenoValve®) in people with Deep Venous Insufficiency (Diagnosis), run by Hancock Jaffe Laboratiores, Inc at 29 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Insufficiency (Diagnosis)
- What is being tested?
- Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 29 sitesUnited States
- Study dates
- 27 Aug 2021to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Albany Medical Center
Albany, New York, 12208
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kaleidahealth
Buffalo, New York, 14203
University of North Carolina
Chapel Hill, North Carolina, 27516
University of Chicago
Chicago, Illinois, 60637
TriHealth
Cincinnati, Ohio, 45220
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44132
Henry Ford Health System
Detroit, Michigan, 48202
Englewood Health
Englewood, New Jersey, 07631
Coastal Vascular
Fort Walton Beach, Florida, 32547
Houston Methodist Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Louisville
Louisville, Kentucky, 40202
Miami Vascular Specialists
Miami, Florida, 33176
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale school of Medicine
New Haven, Connecticut, 06510
NYU Langone
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Stony Brook Medicine
New York, New York, 11794
Sentara
Norfolk, Virginia, 23507
UPMC
Pittsburgh, Pennsylvania, 15232
University of Utah
Salt Lake City, Utah, 84132
Saint Louis University
St Louis, Missouri, 63110
Jobst Vascular Institute / Promedica Toledo Hospital
Toledo, Ohio, 43606
St. Peter's Vascular Associates
Troy, New York, 12180
Pima Heart and Vascular
Tucson, Arizona, 85719
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: 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).
Read the 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.
- Conditions
- Deep Venous Insufficiency (Diagnosis)
- Being tested
- Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hancock-Jaffe bioprosthetic venous valve (VenoValve®)Device
Surgical implantation of the VenoValve device
| Study group | Role | What they receive |
|---|---|---|
| VenoValve | Experimental | Subjects who receive VenoValve implant Receives: Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Major Adverse Event rates
Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, and Pulmonary Embolism
Measured: 3, 6, 12 months and annually thereafter through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start27 Aug 2021
- Primary completion18 Oct 2024
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Venous Insufficiency (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hancock Jaffe Laboratiores, Inc
- Sponsor type
- Research network
- Collaborators
- AXIOM Real Time Metrics, Syntactx
- Responsible party
- Sponsor
- Investigators
- Marc Glickman, MD, Study director, Hancock Jaffe Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943172
- Sponsor's protocol ID
- P061
- Acronym
- SAVVE
- Status last verified
- Feb 2025
- First submitted
- 21 Jun 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35129407
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study
- ClinicalTrials.gov ID
- NCT04943172
- Acronym / sponsor ID
- SAVVE / P061
- Conditions
- Deep Venous Insufficiency (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hancock Jaffe Laboratiores, IncResearch network
- Collaborators
- AXIOM Real Time Metrics, Syntactx
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VenoValve | Experimental | Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)Subjects who receive VenoValve implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hancock-Jaffe bioprosthetic venous valve (VenoValve®)Surgical implantation of the VenoValve device | Device | VenoValve |
Primary outcome
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
1 secondary outcome
Major Adverse Event rates
Time frame: 3, 6, 12 months and annually thereafter through 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 35129407Ulloa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Glickman, MD study director
Hancock Jaffe Laboratories, Inc
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hancock-Jaffe bioprosthetic venous valve (VenoValve®) in people with Deep Venous Insufficiency (Diagnosis), run by Hancock Jaffe Laboratiores, Inc at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary safety endpoint is the composite of the following Major Adverse Events: (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.