Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proxima… (NCT05622500) | Clinical Trial Compass
TerminatedNot Applicable
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease
Stopped: The trial failed to meet the milestones in the internal pilot of feasibility. The trial was redesigned to improve its deliverability and reduce burden to sites prior to being relaunched. Unfortunately, the trial failed to sufficiently recruit.
United Kingdom12 participantsStarted 2022-09-03
Plain-language 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).
Who can participate
Age range18 Years – 100 Years
SexALL
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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