Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease (BEST)
Chronic Venous Insufficiency, Chronic Venous Thrombosis, Iliac Vein Stenosis
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring Deep venous stenting, Intravascular ultrasound, Post thrombotic syndrome, Non-thrombotic iliac vein lesions, Proximal venous outflow obstruction, Chronic venous disease
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Contraindications to stenting (e.g. anatomically unsuitable, contrast allergy) Contraindications to prolonged anticoagulation Existing diagnosis of profound pro-thrombotic states (Beh et's, anti-phospholipid syndrome) Caval occlusion at or proximal to the level of the renal veins Open / hybrid open-endovascular deep venous intervention Pregnancy Inability to provide consent Need to intervene caudal to common femoral vein confluence to achieve inflow Participants that have tested positive for coronavirus within the last 3 months
Sites / Locations
- Imperial College Healthcare NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Best endovenous reconstruction + best medical treatment (compression +/- anti-thrombotic therapy).
Best medical treatment alone (compression +/- anticoagulation).
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).
The comparator arm will consist of participants receiving best medical treatment alone.