Last updated: February 21, 2022
Sponsor: Pirogov Russian National Research Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Varicose Veins
Venous Thrombosis
Vascular Diseases
Treatment
N/AClinical Study ID
NCT04231942
ECOS-VVR
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age over 18 years;
- Varicose veins (VVs) in the system of great saphenous vein (GSV) of one lower limb;
- Performed endovenous thermal ablation (ETA) of the GSV trunk - endovenous laserablation (EVLA) or radiofrequency ablation (RFA) - and elimination of varicosetributaries by mini (micro) phlebectomy or sclerotherapy during the 30-45 days beforeenrollment;
- The technical success of the performed ETA, the absence of reflux in the GSV trunk andthe absence of residual VVs;
- Lack of signs of chronic venous disease (CVD): clinical class of C0-1 according to theClinical-Etiology-Anatomy-Pathophysiology (CEAP) classification;
- Lack of vein-specific symptoms - the intensity of any validated vein-specific symptomis less than 30% according to the numeric rating scale (NRS);
- Signed informed consent.
Exclusion
Exclusion Criteria:
- Bilateral VVs;
- Primary reflux outside the GSV trunk (including combined);
- History of deep or superficial veins thrombosis;
- Verified deep vein reflux;
- Verified non-thrombotic or post-thrombotic venous obstruction;
- Verified pelvic venous insufficiency;
- Persistence of superficial reflux after ETA;
- A tendency for recanalization of previously obliterated veins;
- Persistence of residual VVs - clinical class of C2 by CEAP;
- Persistence of signs of CVD - clinical class of C3 and higher by CEAP;
- Persistence of one or more vein-specific symptom with an intensity of 30% and higherby NRS;
- The need for long-term use of elastic compression;
- Contraindications or restrictions for the long-term use of GCS;
- The need for long-term use of vein-active drugs (more than 1 month);
- Refusal to participate in the study.
Study Design
Total Participants: 700
Study Start date:
December 16, 2019
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Moscow Clinical Hospital name by A.K. Yeramishantsev
Moscow,
Russian FederationActive - Recruiting
Moscow Clinical Hospital no.24
Moscow,
Russian FederationActive - Recruiting
Moscow private medical clinic "MedSwiss"
Moscow,
Russian FederationActive - Recruiting
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