Chronic Venous Insufficiency, CVIPhase 2/3TAVVENCT07609927
Clinical Investigation of Safety and Effectiveness for the enVVe® System
A Phase 2/3 study testing envve system in people with Chronic Venous Insufficiency, CVI, run by Hancock Jaffe Laboratiores, Inc.
Trial summary
A staged prospective, randomized, non-blinded, multicenter study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, CVI
- What is being tested?
- envve system
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jul 2033
- Phase
- Phase 2/3
- 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
- Persistent symptoms with at least 3 months of routine care including compression therapy, pneumatic compression, and in C6 patients, wound care with FDA approved medications or dressing solutions
- Axial deep reflux >1 sec. in the femoral vein (above the P1 segment) and popliteal vein
- Primary or Secondary deep venous valvular incompetence
- CEAP score: C4b, C4c, C5, or C6
- Age ≥18 years
- Ability to stand for duplex ultrasound
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- Ability to ambulate without assistance with appropriate heel to toe ambulation
- Able to attend scheduled post-treatment follow-up visits
- Absence of superficial reflux of the truncal vessels
- BMI <40
- Female patients of childbearing potential must:
- have a 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.
- Pre-implant Venography and Imaging Inclusion Criteria
- Diameter of the Target Vein Zone of 7.5 mm - 11.5 mm (the diameter is the largest of proximal, mid, and distal sections of the Target Vein Zone measured with venography required prior to or during the procedure and IVUS performed during the procedure), as well as with Duplex Ultrasound imaging per Imaging Manual
- Diameter of the popliteal vein must be ≥4.7 mm to accommodate a 14 Fr Introducer sheath
- Planned placement of the enVVe Valve will not cover collateral veins
Who cannot join
- Known hypercoagulable condition including Factor V Leiden deficiency (homozygote), Prothrombin gene Mutation (homozygote), Antithrombin 3 deficiency, Protein C deficiency, Protein S deficiency and Antiphospholipid antibody
- Any active cancer or cancer within 6 months of remission (excluding non-melanoma skin cancer)
- Previous surgical procedure or endovascular procedure in the Target Vein Zone in the target extremity (ipsilateral leg)
- Acute Deep Venous Thrombosis (DVT) or pulmonary embolism (PE) within 30 days of the procedure
- Arterial insufficiency demonstrated by an ABI <0.71 within 6 months
- Patients with primary Lymphedema Praecox or Tarda
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- Superficial ablation ≤ 3 months of the procedure
- Unable to lie prone on the table
- Major surgery or prolonged hospitalization within 8 weeks of the procedure
- Patients with recurrent congestive heart failure (NYHA stage III)
- Patients with chronic narcotic or other drug use for chronic pain other than treatment for their CVI, or a history of substance (e.g. drug, alcohol) abuse
- Uncontrolled diabetes mellitus; A1C levels >13, toxic thyroidism, Tuberculosis (TB), neoplasm, sepsis, blood dyscrasias or acute respiratory or skin disease
- Immobilization or inability to ambulate or with muscle wasting of the target extremity (ipsilateral leg). Unable to perform a heal/toe movement when walking
- Contraindication for anticoagulation or unwillingness to comply with long-term anticoagulation regimen (Heparin, low molecular weight (LMW) heparin by injection twice a day for 30 days, direct oral anticoagulation (DOAC) such as Xarelto or Eliquis for 5 years, Clopidogrel daily for at least 6 months)
- Contraindication for contrast injection procedures (contrast allergy that cannot be medically managed, renal insufficiency/chronic kidney disease with potentially worsening renal function) and when CO2 imaging is not an option or unavailable
- Known nitinol sensitivity/ nickel sensitivity/ porcine tissue sensitivity or polyethylene terephthalate (PET) sensitivity
- Active superficial thrombophlebitis
- Thrombocytosis / platelets > 1 million
- Patients that will not allow needed blood and/or blood products (e.g., transfusion)
- Patients that have placement of stents within the ipsilateral femoral or popliteal veins
- Patients who have had balloon angioplasty of the ipsilateral femoral or popliteal veins within the past 6 months or are clinically determined to require such a procedure imminently. (waiting period of 6 months following balloon angioplasty is required)
- Adults who lack the capacity to provide informed consent
- Patients with life expectancy <5 year due to illness/cancer
- Patients on renal dialysis
- Patients with previously implanted VenoValve in the ipsilateral or contralateral extremity
- Venous outflow obstruction of the iliac vein of > 60% (waiting period of 3 months following iliac vein stenting)
- Extensive infrainguinal obstruction of the deep venous system or Common Femoral Vein (CFV)
- Tortuous anatomy that precludes use of the enVVe System
- Non dominant femoral vein with significant competing flow in the collaterals
- Large competitive flow through the profunda vein near the confluence of the popliteal vein
- Any organ transplant, excluding ophthalmic related transplants
- Patients who are currently using any non-FDA-approved medication for the treatment of venous disease (e.g., venoactive drugs, compounds or supplements such as purified flavonoid fractions like diosmin and hesperidin)
- rVCSS scores of ≤ 7 at baseline
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marc H Glickman, MD contact
About this study
Official title: The TrAnscatheter Venous Valve Endoprosthesis Clinical Investigation of Safety and Effectiveness for the enVVe® System
A staged prospective, randomized, non-blinded, multicenter study.
Read the detailed description
The enVVe System is intended to treat insufficiency in the deep vein system by replacing the function of incompetent valves and to improve unidirectional flow within the deep system thereby decreasing venous hypertension within the lower extremity. The ability to improve venous insufficiency potentially affords the patient long-term relief from symptoms that are a direct result of venous reflux.
Reported data suggests, reduction of regurgitant volume decreases clinical symptoms of CVI including the incidence and occurrence of venous ulceration and edema and affords the patient improved quality of life.
By providing a functional lower extremity venous valve, the enVVe System is designed to provide an effective CVI treatment option for patients with severe deep venous disease (CEAP C4b to C6).
- Conditions
- Chronic Venous Insufficiency, CVI
- Being tested
- envve system
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
envve systemDevice
Catheter based valve system
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint is the composite of all cause death and specified events that are adjudicated to be serious and related to the Device by the CEC measured at 30 days.
Specified DRSAEs:
- Pulmonary Embolism (PE)
- enVVe Valve Embolization
- enVVe Valve Infection
- Target Vein Zone Thrombosis/DVT
- Target Vein Zone perforation requiring endovascular or surgical intervention
- Access Site Bleeding
Measured: 30 Days
Primary Effectiveness Endpoint
The primary effectiveness endpoint is the change in regurgitant (reflux) volume in the Target Vein Zone at 12 months, comparing the Treatment Arm and the Control Arm, as measured per Imaging Manual protocols and assessed by the core laboratory. For subjects in the Treatment Arm, regurgitant volume at 12 months will be measured through the enVVe Valve or, if imaging artifact or noise is present, at the nearest caudal location. For all study arms, only subjects demonstrating forward flow through the applicable imaged segment will be considered evaluable for the primary effectiveness endpoint.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency, CVIStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hancock Jaffe Laboratiores, Inc
- Sponsor type
- Research network
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609927
- Sponsor's protocol ID
- P322
- Acronym
- TAVVE
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TrAnscatheter Venous Valve Endoprosthesis Clinical Investigation of Safety and Effectiveness for the enVVe® System
- ClinicalTrials.gov ID
- NCT07609927
- Acronym / sponsor ID
- TAVVE / P322
- Conditions
- Chronic Venous Insufficiency, CVI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hancock Jaffe Laboratiores, IncResearch network
- Collaborators
- NAMSA
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2033 (estimated)
- First posted
- 27 May 2026 (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 staged prospective, randomized, non-blinded, multicenter study.
Detailed description
The enVVe System is intended to treat insufficiency in the deep vein system by replacing the function of incompetent valves and to improve unidirectional flow within the deep system thereby decreasing venous hypertension within the lower extremity. The ability to improve venous insufficiency potentially affords the patient long-term relief from symptoms that are a direct result of venous reflux.
Reported data suggests, reduction of regurgitant volume decreases clinical symptoms of CVI including the incidence and occurrence of venous ulceration and edema and affords the patient improved quality of life.
By providing a functional lower extremity venous valve, the enVVe System is designed to provide an effective CVI treatment option for patients with severe deep venous disease (CEAP C4b to C6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Persistent symptoms with at least 3 months of routine care including compression therapy, pneumatic compression, and in C6 patients, wound care with FDA approved medications or dressing solutions
- Axial deep reflux >1 sec. in the femoral vein (above the P1 segment) and popliteal vein
- Primary or Secondary deep venous valvular incompetence
- CEAP score: C4b, C4c, C5, or C6
- Age ≥18 years
Key exclusion criteria (33 listed)
- Known hypercoagulable condition including Factor V Leiden deficiency (homozygote), Prothrombin gene Mutation (homozygote), Antithrombin 3 deficiency, Protein C deficiency, Protein S deficiency and Antiphospholipid antibody
- Any active cancer or cancer within 6 months of remission (excluding non-melanoma skin cancer)
- Previous surgical procedure or endovascular procedure in the Target Vein Zone in the target extremity (ipsilateral leg)
- Acute Deep Venous Thrombosis (DVT) or pulmonary embolism (PE) within 30 days of the procedure
- Arterial insufficiency demonstrated by an ABI <0.71 within 6 months
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 |
|---|---|---|
| envve systemCatheter based valve system | Device | – |
Primary outcome
Primary Safety Endpoint
Time frame: 30 Days
The primary safety endpoint is the composite of all cause death and specified events that are adjudicated to be serious and related to the Device by the CEC measured at 30 days. Specified DRSAEs: * Pulmonary Embolism (PE) * enVVe Valve Embolization * enVVe Valve Infection * Target Vein Zone Thrombosis/DVT * Target Vein Zone perforation requiring endovascular or surgical intervention * Access Site Bleeding
Primary Effectiveness Endpoint
Time frame: 12 months
The primary effectiveness endpoint is the change in regurgitant (reflux) volume in the Target Vein Zone at 12 months, comparing the Treatment Arm and the Control Arm, as measured per Imaging Manual protocols and assessed by the core laboratory. For subjects in the Treatment Arm, regurgitant volume at 12 months will be measured through the enVVe Valve or, if imaging artifact or noise is present, at the nearest caudal location. For all study arms, only subjects demonstrating forward flow through the applicable imaged segment will be considered evaluable for the primary effectiveness endpoint.
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 27 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marc H Glickman, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing envve system in people with Chronic Venous Insufficiency, CVI, run by Hancock Jaffe Laboratiores, Inc.
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 18 inclusion and 33 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Marc H Glickman, MD (MGlickman@envveno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.