Clinical Investigation of Safety and Effectiveness for the enVVe® System

NCT07609927 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: P322
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

A staged prospective, randomized, non-blinded, multicenter study.

Conditions

Chronic Venous Insufficiency, CVI

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  12 months

Interventions

envve system DEVICE

Catheter based valve system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hancock Jaffe Laboratiores, Inc: lead
• NAMSA: collaborator

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marc H Glickman, MD

CONTACT

MGlickman@envveno.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2033
• Last Updated: May 27, 2026

Record last verified: 2026-05