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:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT07208695
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older, with a confirmed diagnosis of primary lower extremity varicose veins (CEAP classification C2-C6) based on clinical examination and duplex ultrasound.
* Underwent endovenous radiofrequency ablation (RFA) of the great saphenous vein as the primary intervention.
* Postoperatively, either: (a) continuously uses standard-dose oral antiplatelet drugs (e.g., aspirin 100mg/day, clopidogrel 75mg/day) or oral anticoagulant drugs (e.g., warfarin with INR maintained at 2.0-3.0, direct oral anticoagulants at standard therapeutic doses) as per clinical routine, or (b) does not use any antithrombotic drugs.
* Able to understand and comply with the follow-up schedule (including 30-day bleeding assessment and 6-month duplex ultrasound examination) and provide informed consent.
Exclusion Criteria:
* Presence of secondary varicose veins caused by deep vein thrombosis, venous malformation, or other vascular disorders.
* History of coagulation disorders (e.g., hemophilia, thrombocytopenia with platelet count \<100×10⁹/L) or use of other antithrombotic agents (e.g., low-molecular-weight heparin, glycoprotein IIb/IIIa inhibitors) postoperatively.
* Major bleeding events (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 3 months prior to RFA.
* Severe hepatic insufficiency (Child-Pugh class C), renal insufficiency (eGFR \<30 mL/min/1.73m²), or other life-threatening systemic diseases.
* Unable to complete follow-up due to mental disorders, mobility limitations, or other reasons, or refusal to sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07208695
Study Brief:
Protocol Section:
NCT07208695