Clinical trial NCT05372146: Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
Official title: Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Varicose Veins of Lower Limb
Keywords: varicose veins
chiva
hemodynamic correction
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)
timeFrame: 12 months
Secondary outcomes:
measure: Varicose veins recurrence
timeFrame: 12 months
measure: Leg discomfort related to CVD symptoms measured with 10-cm visual analogue scale (VAS) at 3 months
timeFrame: 2nd day, 7th day, 1 months, 3 months
measure: In a study group remained GSV trunk diameter at mid- and lower thigh was measured at 1, 3, 6, 12 months after procedure
timeFrame: 1 months, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Veronika Golovina
Study officials:
References: