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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT07219758
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form;
2. Participant is 18 years of age and older;
3. Neurologically stable;
4. Ambulatory;
5. Symptomatic chronic venous insuSciency (CVI), with edema or pain, (CEAP classification of C3 or greater);
6. Flow-limiting venous outflow obstruction (\>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and
7. Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
Exclusion Criteria:
1. Comorbidity risks which may limit longevity (\<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
3. History of stroke within the last 6 months;
4. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
5. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks of consent;
6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months of consent;
7. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
8. Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;
9. Pregnant and/or breastfeeding;
10. Patients with cognitive impairments who are unable to be consented;
11. Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
12. COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk; and
13. Patients considered to belong to a vulnerable population.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07219758
Study Brief:
Protocol Section:
NCT07219758