RCT Comparing Standard Cannula Delivered FS, UGFS and ClariVein® in the Management of SVI

Launched by HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST · Dec 9, 2013

Keywords

ClinConnect Summary

. Investigational Plan Study Design This is a single centre three armed parallel group study with equal randomisation. The trial will be conducted in the Academic Vascular Surgical Unit of Hull York Medical School based at Hull Royal Infirmary, a university teaching hospital.

Target population The target population for this study are individuals with symptoms of SVI with ultrasound evidence of axial vein reflux and who have agreed to receive treatment for their axial vein reflux.

Recruitment Each patient referred to the vascular service with symptomatic SVI is assessed. Patients who poten...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Aged 18 or over
• • Symptomatic superficial venous insufficiency; Clinical grades C2 - C6; which will likely benefit from treatment in the opinion of an experienced specialist and the participant
• • Superficial axial incompetence with proposed treatment lengths of \>10cm. This axis may be a great saphenous vein (GSV), anterior accessory saphenous vein (ASV), small saphenous vein (SSV) or Giacomini vein (GV). Multiple veins can be treated.
• • The proposed treatment length is straight enough to be cannulated with the catheter devices and the SVI is suitable for treatment with any modality in the study in the view of an experienced specialist
• • Willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent
• Exclusion Criteria:
• • • Inability to give informed written consent
• • Unsuitable for any of the treatments in the opinion of a suitably experienced specialist.
• • Unwilling or inability to comply with the requirements for follow-up visits.
• • Known allergy to any of the key medications used in the treatment protocols
• • Known right to left circulatory shunt
• • Evidence of deep venous thrombosis or occlusion
• • Active or recent thrombophlebitis (within 6 weeks)
• • Impalpable foot pulses and an Ankle-Brachial Pressure Index of less than 0.8
• • Pregnancy
• • Active malignancy
• • Immobility