Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients

NCT05372146 | Completed

• 1 other identifier: 192
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins; Varicose Veins of Lower Limb

Keywords

varicose veins; chiva; hemodynamic correction

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)

  There are 20 questions in the CIVIQ-20, each with 5 possible answers (1 to 5), the minimum possible score being 20 and the maximum 100. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (100-20=80), multiplied by 100.

  12 months

Secondary Outcomes (3)

• Varicose veins recurrence

  12 months

• Leg discomfort related to CVD symptoms measured with 10-cm visual analogue scale (VAS) at 3 months

  2nd day, 7th day, 1 months, 3 months

• In a study group remained GSV trunk diameter at mid- and lower thigh was measured at 1, 3, 6, 12 months after procedure

  1 months, 3 months, 6 months, 12 months

Study Arms (2)

CHIVA group

EXPERIMENTAL

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.

Procedure: GSV radiofrequency ablation with concomitant phlebectomy

Control group

ACTIVE COMPARATOR

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.

Procedure: GSV radiofrequency ablation with concomitant phlebectomy

Interventions

GSV radiofrequency ablation with concomitant phlebectomy PROCEDURE

Radiofrequency ablation with concomitant phlebectomy

CHIVA group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• C4-C6 class of CEAP
• Pregnancy
• Deep vein reflux more than 1 sec
• SSV reflux more than 0,5 sec
• Those unwilling to sign an informed consent were also included.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Veronika Golovina

Moscow, 109044, Russia

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 12, 2022
• Study Start: November 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: February 27, 2022
• Last Updated: May 19, 2022

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)