A randomized controlled multicenter trial comparing modern great saphenous vein stripping with crossectomy, with modern great saphenous vein stripping without crossectomy and radiofrequency ablation for primary great saphenous vein incompetence (STRIP trial). - STRIP trial

Atrium Medisch Centrum0 个研究点目标入组 600 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•-Patients with primary varicosity of the GSV, between age 18-80 year.
•-CEAP 2-4(Appendix B/VI), without deep vein insufficiency.
•-Minimum distance between skin and the GSV in the first 20 cm from the SFJ >5mm.
•-Minimum length of to be treated GSV 10cm.
•-GSV on one side will be treated in the case of bilateral insufficiency.
•-GSV will be treated only in the case of solitary GSV insufficiency.
•-Patients treated by experienced surgeon/center.

•-Age <18 years or >80 years.
•-Deep vein insufficiency in the same extremity (duplex verified).
•-Previous thrombosis of the affected limb (secondary thrombosis)
•-Tortuosity of the GSV, double GSV system.
•-Superficial veins with a distance of <5mm to the skin surface ( RF cannot be applied), as measured at echo-duplex.
•-Patients with double GSV's and/or lateral accessory insufficient branch.
•-Earlier operation of the GSV with crossectomy/stripping(recurrency).
•-Operated for small saphenous vein (SSV) incompetence the last 3 months.
•-Known ABI <0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
•-Patients with active malignancy.
•-Patients with other known medical condition that contradict any of the treatments in the study.
•-History of CVA/central nervous system disease
•-Pregnancy
•-Patients treated with coumarine derivates, if cannot be interrupted during treatment(switched to a LMWH).
•-Pacemaker

发起方

Atrium Medisch Centrum