Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease

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).

Inclusion Criteria:Adult patients with chronic venous disease secondary to chronic proximal thrombotic or nonthrombotic stenosis or occlusionDisease in iliac and/or caval deep venous system(s)CEAP clinical C3, C4, C5, C6 or symptoms of venous claudicationAnatomically suitable for endovenous reconstructionExclusion Criteria:Contraindications to stenting (e.g. anatomically unsuitable, contrast allergy)Contraindications to prolonged anticoagulationExisting diagnosis of profound pro-thrombotic states (Beh et's, anti-phospholipid syndrome)Caval occlusion at or proximal to the level of the renal veinsOpen / hybrid open-endovascular deep venous interventionPregnancyInability to provide consentNeed to intervene caudal to common femoral vein confluence to achieve inflowParticipants that have tested positive for coronavirus within the last 3 months