Clinical trial NCT04943172: The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study
Official title: The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deep Venous Insufficiency (Diagnosis)
Lead sponsor: Hancock Jaffe Laboratiores, Inc
Sponsor class: NETWORK
Collaborators: name: AXIOM Real Time Metrics
name: Syntactx
First posted: 2021-06-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary safety endpoint is the composite of the following Major Adverse Events:
timeFrame: 30 days
Secondary outcomes:
measure: Major Adverse Event rates
timeFrame: 3, 6, 12 months and annually thereafter through 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: New Haven
country: United States
facility: Yale school of Medicine
state: Connecticut
city: Fort Walton Beach
country: United States
facility: Coastal Vascular
state: Florida
city: Miami
country: United States
facility: Miami Vascular Specialists
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Kaleidahealth
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Stony Brook Medicine
state: New York
city: Troy
country: United States
facility: St. Peter's Vascular Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute / Promedica Toledo Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Sentara
state: Virginia
Study officials:
affiliation: Hancock Jaffe Laboratories, Inc
name: Marc Glickman, MD
role: STUDY_DIRECTOR
References:
citation: 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.