Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03216005
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
* Failed compression therapy of at least 6 months' duration;
* Deep system venous reflux characterized by \>1 second reflux time;
* Presence of at least one target site within the target vessel.
Exclusion Criteria:
* Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
* Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
* Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels;
* Acute deep venous thrombosis (DVT) within 3 months of consent;
* History of stroke within the last 6 months;
* Flow-limiting venous outflow obstruction central to the intended target sites;
* Insufficient inflow through the treatment vein upon manual augmentation;
* Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
* Chronic renal insufficiency with creatinine level of ≥2mg/dL;
* Hemoglobin level \<9.0 mg/dL;
* Platelet count \<50,000 or \>1,000,000 per mm3;
* Total white blood cell count \<3,000/mm3;
* Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
* Non-ambulatory patients;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03216005
Study Brief:
Protocol Section:
NCT03216005