The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Venous Insufficiency
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Adult patients with chronic, axial deep venous reflux secondary to previous deep venous thrombosis (post-thrombotic syndrome) or primary reflux.
    2. Those have failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care
    3. Axial deep reflux >1000 msec. at the level of the popliteal vein
    4. Venous valvular incompetence from primary or secondary causes
    5. CEAP score: C4b, C4c, C5, or C6
    6. Diameter of native target vein > = 8 mm
    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 a negative pregnancy test at the screening visit or within 7 days of the index procedure, whichever is later, not pregnant or breastfeeding and agreed to use medically acceptable contraceptive methods

You may not be eligible for this study if the following are true:

    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 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



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