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The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

Sponsor
Hancock Jaffe Laboratiores, Inc (Other)
Overall Status
Recruiting
CT.gov ID
NCT04943172
Collaborator
AXIOM Real Time Metrics (Other), Syntactx (Other)
75
Enrollment
24
Locations
1
Arm
78.1
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: VenoValve

Subjects who receive VenoValve implant

Device: Hancock-Jaffe bioprosthetic venous valve (VenoValve®)
Surgical implantation of the VenoValve device

Outcome Measures

Primary Outcome Measures

  1. The primary safety endpoint is the composite of the following Major Adverse Events: [30 days]

    Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, Pulmonary embolism in 75 patients. Rate of >9% is expected

Secondary Outcome Measures

  1. Major Adverse Event rates [3, 6, 12 months and annually thereafter through 5 years]

    Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, and Pulmonary Embolism

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Pima Heart and Vascular Tucson Arizona United States 85719
3 Cedars-Sinai Medical Center Beverly Hills California United States 90211
4 Yale school of Medicine New Haven Connecticut United States 06510
5 Coastal Vascular Fort Walton Beach Florida United States 32547
6 Miami Vascular Specialists Miami Florida United States 33176
7 University of Chicago Chicago Illinois United States 60637
8 Indiana University Indianapolis Indiana United States 46202
9 Henry Ford Health System Detroit Michigan United States 48202
10 Saint Louis University Saint Louis Missouri United States 63110
11 Englewood Health Englewood New Jersey United States 07631
12 Albany Medical Center Albany New York United States 12208
13 Kaleidahealth Buffalo New York United States 14203
14 NYU Langone New York New York United States 10016
15 Stony Brook Medicine New York New York United States 11794
16 University of North Carolina Chapel Hill North Carolina United States 27516
17 TriHealth Cincinnati Ohio United States 45220
18 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44132
19 Jobst Vascular Institute / Promedica Toledo Hospital Toledo Ohio United States 43606
20 UPMC Pittsburgh Pennsylvania United States 15232
21 Vanderbilt University Medical Center Nashville Tennessee United States 37232
22 Houston Methodist Hospital Houston Texas United States 77030
23 University of Utah Salt Lake City Utah United States 84132
24 Sentara Norfolk Virginia United States 23507

Sponsors and Collaborators

  • Hancock Jaffe Laboratiores, Inc
  • AXIOM Real Time Metrics
  • Syntactx

Investigators

  • Study Director: Marc Glickman, MD, Hancock Jaffe Laboratories, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hancock Jaffe Laboratiores, Inc
ClinicalTrials.gov Identifier:
NCT04943172
Other Study ID Numbers:
  • P061
First Posted:
Jun 29, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Venous Insufficiency

Study Results

No Results Posted as of Aug 8, 2022