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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT05622500
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients with chronic venous disease secondary to chronic proximal thrombotic or nonthrombotic stenosis or occlusion
2. Disease in iliac and/or caval deep venous system(s)
3. CEAP clinical C3, C4, C5, C6 or symptoms of venous claudication
4. Anatomically suitable for endovenous reconstruction
Exclusion Criteria:
1. Contraindications to stenting (e.g. anatomically unsuitable, contrast allergy)
2. Contraindications to prolonged anticoagulation
3. Existing diagnosis of profound pro-thrombotic states (Beh et's, anti-phospholipid syndrome)
4. Caval occlusion at or proximal to the level of the renal veins
5. Open / hybrid open-endovascular deep venous intervention
6. Pregnancy
7. Inability to provide consent
8. Need to intervene caudal to common femoral vein confluence to achieve inflow
9. Participants that have tested positive for coronavirus within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05622500
Study Brief:
Protocol Section:
NCT05622500