Varicose VeinsNCT05372146
Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
A study testing GSV radiofrequency ablation with concomitant phlebectomy in people with Varicose Veins and Varicose Veins of Lower Limb, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Varicose Veins of Lower Limb
- What is being tested?
- GSV radiofrequency ablation with concomitant phlebectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2019to 27 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- GSV radiofrequency ablation with concomitant phlebectomy
- Keywords
- varicose veins, chiva, hemodynamic correction
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSV radiofrequency ablation with concomitant phlebectomyProcedure or surgery
Radiofrequency ablation with concomitant phlebectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: GSV radiofrequency ablation with concomitant phlebectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Varicose veins recurrence
Visual recurrence of varicose veins
Measured: 12 months
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).
Measured: 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
Diameter of GSV measured by ultrasound
Measured: 1 months, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Nov 2019
- Primary completion1 Sep 2020
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372146
- Sponsor's protocol ID
- 192
- Status last verified
- Nov 2019
- First submitted
- 3 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
- ClinicalTrials.gov ID
- NCT05372146
- Acronym / sponsor ID
- 192
- Conditions
- Varicose Veins, Varicose Veins of Lower Limb
- Keywords
- varicose veins, chiva, hemodynamic correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This was a single-center, prospective, non-randomized, non-inferiority comparative study conducted on patients with primary varicose veins
| Arm | Type | Receives |
|---|---|---|
| CHIVA group | Experimental | Procedure: GSV radiofrequency ablation with concomitant phlebectomy43 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. |
| Control group | Active comparator | Procedure: GSV radiofrequency ablation with concomitant phlebectomy43 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSV radiofrequency ablation with concomitant phlebectomyRadiofrequency ablation with concomitant phlebectomy | Procedure or surgery | CHIVA group, Control group |
Primary outcome
Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)
Time frame: 12 months
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.
3 secondary outcomes
Varicose veins recurrence
Time frame: 12 months
Leg discomfort related to CVD symptoms measured with 10-cm visual analogue scale (VAS) at 3 months
Time frame: 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
Time frame: 1 months, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSV radiofrequency ablation with concomitant phlebectomy in people with Varicose Veins and Varicose Veins of Lower Limb, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.