Varicose Veins Clinical Trial
Official title:
Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
NCT number | NCT05372146 |
Other study ID # | 192 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | February 27, 2022 |
Verified date | November 2019 |
Source | Pirogov Russian National Research Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | February 27, 2022 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Veronika Golovina | Moscow |
Lead Sponsor | Collaborator |
---|---|
Pirogov Russian National Research Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Varicose veins recurrence | Visual recurrence of varicose veins | 12 months | |
Secondary | Leg discomfort related to CVD symptoms measured with 10-cm visual analogue scale (VAS) at 3 months | Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). |
2nd day, 7th day, 1 months, 3 months | |
Secondary | In a study group remained GSV trunk diameter at mid- and lower thigh was measured at 1, 3, 6, 12 months after procedure | Diameter of GSV measured by ultrasound | 1 months, 3 months, 6 months, 12 months |
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