Status:
COMPLETED
Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Varicose Veins
Varicose Veins of Lower Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
86 patients were randomized into hot-CHIVA (n=43) and control (n=43) groups. Study group patients had undergone radiofrequency ablation (RFA) VNUS Closure - FastTM of one segment of GSV close to saphe...
Detailed Description
Aim - to compare GSV segmental radiofrequency ablation (hot-CHIVA) and conventional GSV ablation in varicose veins patients. This was a single-center, prospective, non-randomized, non-inferiority com...
Eligibility Criteria
Inclusion
- C2EpAsPrGSVa, C2,3EpAsPrGSVa
- Reflux not lower than upper part of the calf,
- Age more than 18 years,
- SFJ diameter less than 15mm,
- Incompetence of terminal-femoral valve,
- GSV reflux more than 0,5 sec,
- re-entry perforator on the thigh or upper part of the calf for patients in the hot-CHIVA group
Exclusion
- C4-C6 class of CEAP
- Pregnancy
- Deep vein reflux more than 1 sec
- SSV reflux more than 0,5 sec
- Interventions for VVs prior to the inclusion
- Those unwilling to sign an informed consent were also included.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05372146
Start Date
November 1 2019
End Date
February 27 2022
Last Update
May 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Veronika Golovina
Moscow, Russia, 109044