Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

NCT ID: NCT05372146

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-02-27

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 saphenofemoral junction. Controls had undergone whole refluxing trunk ablation. Additional phlebectomy was performed in all the patients of both groups. Primary end-point was change in quality of life (QoL) measured with CIVIQ-20 at 12 months. Secondary end-points was recurrence of varicose veins at 12 months. The investigators also measured GSV caliber at the median and distal thigh change in hot-CHIVA group.

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 comparative study conducted on patients with primary varicose veins. In a study group (hot-CHIVA) GSV segmental ablation with concomitant phlebectomy was performed. Conventional GSV radiofrequency ablation was performed in a control group. Patients were enrolled from November, 2019 to February, 2021.

All patients were examined clinically. Age, height, weight, body mass index, gender, side of disease, personal history of varicose veins were recorded. Medical history was taken. Disease description was made using advanced CEAP classification. Quality of life was measured by CIVIQ-20 and leg discomfort related to CVD symptoms on the operated leg was measured with a 10-cm visual analogue scale (VAS). Duplex ultrasound was performed in a standing position to access deep veins and GSV. We recorded reflux extention and presence of the re-entry perforators on the thigh or upper calf. Diameter of GSV near SFJ, at the middle, and lower part of the thigh was measured at inclusion in the both groups.

Sample size The sample size was calculated considering the average values for the CIVIQ-20 quality of life questionnaire on 2nd year after the endovascular treatment and CHIVA treatment obtained by reviewing the literature. Selected parameters: first-order error (α) 5%; power 80%; boundaries of "non-inferiority limit" 2; the expected difference between the study groups of 0. Taking into account the possible dropout of patients from the study, the size of the groups is increased by 5%. The estimated sample size is 86 participants.

Statistical analysis Data are presented using descriptive statistics. Normally distributed data are presented as mean with standard deviation. Not normally distributed data are presented as (Me) and interquartile range (Q1 - Q3). Two independent groups were compared with Student's t-test or Mann-Whitney test depending on data distribution. Friedman test was used to compare dependent variables. Pearson's chi-squared test or Fisher's exact test were used to compare nominal variables. A p-value of <0.05 was considered statistically significant.

Conditions

Varicose Veins; Varicose Veins of Lower Limb

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CHIVA group

43 participants. In the study group patients GSV was punctured 20-25 cm below SFJ. Radiofrequency catheter (ClosureFast) was inserted and positioned at SFJ distally to the superficial iliac circumflex vein. Four cycles were used for one segment below SFJ. After that catheter cooled down to 40C and was extracted. Phlebectomy was performed using Varady hooks after thermal ablation in both groups. All procedures were performed under tumescent anesthesia.

Group Type: EXPERIMENTAL

GSV radiofrequency ablation with concomitant phlebectomy

Intervention Type: PROCEDURE

Radiofrequency ablation with concomitant phlebectomy

Control group

43 participants. In the controls GSV was punctured at a distal part of a refluxing segment. Catheter was positioned at SFJ and conventional radiofrequency procedure was performed with four cycles below SFJ and two cycles for every next segment. Phlebectomy was performed using Varady hooks after thermal ablation in both groups. All procedures were performed under tumescent anesthesia.

Group Type: ACTIVE_COMPARATOR

GSV radiofrequency ablation with concomitant phlebectomy

Intervention Type: PROCEDURE

Radiofrequency ablation with concomitant phlebectomy

Interventions

GSV radiofrequency ablation with concomitant phlebectomy

Radiofrequency ablation with concomitant phlebectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pirogov Russian National Research Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Veronika Golovina

Moscow, , Russia

Countries

Russia

Other Identifiers

192

Identifier Type: -

Identifier Source: org_study_id