Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease - the BEST Multi-centre Randomised Controlled Trial

Status: Terminated
Location: See location...
Intervention Type: Procedure, Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic obstruction of the iliac veins or inferior vena cava can occur as a result of deep vein thrombosis (DVT), or due to extrinsic compression in non-thrombotic iliac vein lesions (NIVLs). This obstruction can manifest as post-thrombotic syndrome (PTS) after DVT or as chronic venous disease (CVD) in NIVL. Despite sparse evidence, rates of venous stenting for PTS and NIVLs are increasing. A pragmatic, observer-blind, multi-centre, randomised-controlled trial for adults with CVD secondary to either PTS or NIVLs randomised to either best endovenous therapy (including venoplasty and deep venous stenting) or standard therapy (compression +/- anticoagulation). Included participants will have chronic venous disease (CEAP classification 3 - 6) secondary to proximal deep venous disease. The primary outcome is severity of venous disease at 6 months as ascertained by the Venous Clinical Severity Score (VCSS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Adult patients with chronic venous disease secondary to chronic proximal thrombotic or nonthrombotic stenosis or occlusion

• Disease in iliac and/or caval deep venous system(s)

• CEAP clinical C3, C4, C5, C6 or symptoms of venous claudication

• Anatomically suitable for endovenous reconstruction

Locations
Other Locations
United Kingdom
Imperial College Healthcare NHS Trust
London
Time Frame
Start Date: 2022-09-03
Completion Date: 2025-04-08
Participants
Target number of participants: 12
Treatments
Experimental: Best endovenous reconstruction + best medical treatment (compression +/- anti-thrombotic therapy).
The intervention arm consists of participants undergoing best endovenous reconstruction under the guidance of intra-vascular ultrasound in addition to best medical treatment (compression +/- antithrombotic therapy).
Active_comparator: Best medical treatment alone (compression +/- anticoagulation).
The comparator arm will consist of participants receiving best medical treatment alone.
Sponsors
Collaborators: British Heart Foundation, University of Edinburgh
Leads: Imperial College London

This content was sourced from clinicaltrials.gov