Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02454452

Enrollment

225

Registered

2015-05-27

Start date

2013-02-28

Completion date

2017-08-31

Last updated

2017-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

Varicose Veins

Brief summary

Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

Detailed description

A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care. The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm. Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.

Interventions

PROCEDURERadiofrequency

Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

PROCEDURESaphenous vein stripping

Saphenous vein stripping

PROCEDURECHIVA

conservative hemodynamic treatment venous insufficiency

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex. * Age \> 18 years * Informed consent

Exclusion criteria

* Recurrent varicose veins * Post-thrombotic syndrome. * Patients with active malignancies or severe ischemic heart disease. * Serious liver disease * Thrombophilia. * Serious psychiatric diseases

Design outcomes

Primary

Measure	Time frame	Description
Absence of venous reflux	2 years	Absence of venous reflux by duplex ultrasound

Secondary

Measure	Time frame	Description
CIVIQ	2 years	Venous quality of Life questionnaire - Spanish validated version
SF-36	2 years	—
VCSS	2 years	Venous Clinical Severity Score
Surgical complications	1 month	Hematoma, echymosis, infection, bleeding, induration, neuritic pain

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026