BEST

• Research type

  Research Study

• Full title

  Best Endovenous treatment, including STenting, versus best non-endovenous treatment in chronic proximal deep venous disease – the BEST multi-centre randomised controlled trial

• IRAS ID

  308755

• Contact name

  Alun Huw Davies

• Contact email

  a.h.davies@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Clinicaltrials.gov Identifier

  NCT05622500

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  THE PROBLEM
  Venous disease is a term used to describe problems that patients may have with the veins in their legs, including blockages in the veins or blood travelling the wrong way in the veins. Chronic obstruction of the iliac veins and inferior vein cava can be secondary to a clot in vein known as post-thrombotic syndrome (PTS) or due to a narrowing known as non-thrombotic iliac vein lesions (NIVLs). Clots in the lower limb veins, known as deep vein thrombosis (DVT) are common. Following a DVT, up to 50% of patients develop PTS. Venous disease can cause heaviness, swelling, itching, aching and problems with doing everyday tasks. Sometimes, when the blood rests near the ankles for a long time, this can cause the skin to break down and a wound (ulcer) to develop.

  THE STUDY
  The main treatments for chronic venous disease are: wearing tight elastic stockings and/or thinning the blood with medicines, or trying to open the narrowed or blocked vein with a stent.
  A deep venous stent is one that is made to be placed high-up in the leg veins. This can help the flow of blood from the leg back to the heart. Placing a stent in the veins is generally a safe procedure but it is unclear if they improve the problems that people with venous disease have. This study will investigate adults with venous disease secondary to either PTS or NIVLs. The study will randomise them to either best endovenous therapy (including venoplasty and deep venous stenting) or standard therapy (compression +/- anticoagulation). The main study outcome will be the severity of venous disease at 6 months, measured using the Venous Clinical Severity Score (VCSS). Participants will be monitored closely will clinical assessment and ultrasound scans at 6 weeks, 6 months and 1 year.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  22/WM/0067

• Date of REC Opinion

  4 Apr 2022

• REC opinion

  Further Information Favourable Opinion