Endovenous RFA Versus Ligation and Striping for Varicose Veins

Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04526626

Enrollment

300

Registered

2020-08-26

Start date

2020-02-01

Completion date

2022-06-30

Last updated

2020-08-26

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

Conditions

Varicose Veins of Lower Limb

Keywords

Radiofrequency ablation, High ligation and striping

Brief summary

Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.

Interventions

DEVICERadiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)

Thermal injury to long saphenous vein

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Diagnosis of long saphenous varicose veins

Exclusion criteria

* Contraindicated to operation due to severe comorbidities

Design outcomes

Primary

Measure	Time frame	Description
Technical success	up to 24 months	Occlusion of the long saphenous vein
Complications	2 weeks after operation	Deep vein thrombosis, skin burn
Recurrence of varicose vein	up to 24 months	Recurrence of varicose vein

Countries

China

Outcome results

None listed

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