This trial is active, not recruiting.

Condition varicose veins
Treatments radiofrequency, saphenous vein stripping, chiva
Phase phase 4
Sponsor Corporacion Parc Tauli
Start date February 2013
End date July 2015
Trial size 207 participants
Trial identifier NCT02454452, CEIC 2012/068


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
Saphenous venous stripping surgical technique
saphenous vein stripping
Saphenous vein stripping
(Active Comparator)
conservative hemodynamic treatment venous insufficiency (CHIVA)
conservative hemodynamic treatment venous insufficiency
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter

Primary Outcomes

Absence of venous reflux
time frame: 2 years

Secondary Outcomes

time frame: 2 years
time frame: 2 years
time frame: 2 years
Surgical complications
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4.5 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

Additional Information

Official title 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.
Principal investigator Elena González Cañas, MD
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 4.5 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Corporacion Parc Tauli.