Investigation of Femoropopliteal In Situ Valve Formation with the InterVene System (INFINITE-US)

Are you eligible to participate in this study?

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

  • Conditions:
    Symptomatic Cvi And Deep Vein Reflux
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects willing and able to sign the approved informed consent form (ICF)
    2. Subjects Willing to comply with follow-up evaluations and protocols
    3. Subjects who are symptomatic CVI subjects, with Clinical Etiological Anatomical Pathophysiological (CEAP) classification of C5 to C6
    4. Subjects failed at least 6 months of conservative therapy
    5. Subjects with deep system venous reflux characterized by >1 second reflux time in two contiguous vein segments
    6. Subjects who has at least two potential target sites within the target vessel as per protocol and the investigator's opinion.
    7. Subjects who, in the investigator's opinion, are good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy

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

    1. Subjects with untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
    2. Subjects who has anatomy that does not support proper device access of the treatment vein through the ipsilateral common femoral or femoral vein
    3. Subjects who have acute deep venous thrombosis (DVT) within 1 year of consent
    4. Subjects who has had deep venous intervention (includes stenting) in the target limb or outflow vessels within 6 months of consent
    5. Subjects who have flow-limiting venous outflow obstruction central to the intended target sites
    6. Subjects who have inadequate flow into or through the target vessel
    7. Luminal diameter that is < 6mm or between 6mm and 7mm for a section of vein > 1cm in length,
    8. A competent vein valve in any vein segment through which the device is likely to be inserted
    9. Contraindications to all protocol specified anticoagulation options
    10. Known and uncontrolled hypercoagulopathy
    11. Women on long-term oral contraceptives
    12. Non-ambulatory patients
    13. Significant peripheral arterial disease
    14. NYHA Class III or IV heart failure
    15. Patients with a history of right heart failure
    16. Active systemic infection
    17. Invasive surgical procedure within the last 3 months that in the Investigator’s opinion would interfere with the study procedure or results
    18. Chronic renal insufficiency with creatinine level of = 2mg/dL
    19. Pregnant or lactating female
    20. Subject is enrolled in another clinical study
    21. Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol

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