Chronic Venous Insufficiency Clinical Trial
— BESTOfficial title:
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease - the BEST Multi-centre Randomised Controlled Trial
NCT number | NCT05622500 |
Other study ID # | 22SM7477 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 3, 2022 |
Est. completion date | May 1, 2026 |
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).
Status | Recruiting |
Enrollment | 328 |
Est. completion date | May 1, 2026 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Adult patients with chronic venous disease secondary to chronic proximal thrombotic or nonthrombotic stenosis or occlusion 2. Disease in iliac and/or caval deep venous system(s) 3. CEAP clinical C3, C4, C5, C6 or symptoms of venous claudication 4. Anatomically suitable for endovenous reconstruction Exclusion Criteria: 1. Contraindications to stenting (e.g. anatomically unsuitable, contrast allergy) 2. Contraindications to prolonged anticoagulation 3. Existing diagnosis of profound pro-thrombotic states (Beh et's, anti-phospholipid syndrome) 4. Caval occlusion at or proximal to the level of the renal veins 5. Open / hybrid open-endovascular deep venous intervention 6. Pregnancy 7. Inability to provide consent 8. Need to intervene caudal to common femoral vein confluence to achieve inflow 9. Participants that have tested positive for coronavirus within the last 3 months |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College Healthcare NHS Trust | London | UK |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | British Heart Foundation, University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Venous Clinical Severity Score (VCSS) at 6 months | Disease severity score. Venous clinical severity score (VCSS) encompasses nine hallmarks of chronic venous disease, each scored on a severity scale from 0 to 3. Min score 0, Max score 30. High score = worse severity of disease. | 6 months | |
Secondary | Re-intervention, number of participants requiring an additional procedure. | Dichotomous outcome, defined as additional procedure undertaken to maintain or re-establish stent patency, | 6 weeks, 3 months, 6 months, 12 months | |
Secondary | Stent patency, dichotomous outcome, number of participants with a patent stent at last follow-up. | Reported as primary, primary-assisted, secondary patency | 6 weeks, 3 months, 6 months, 12 months | |
Secondary | Cost-effectiveness of deep venous reconstruction | ICER | 12 months | |
Secondary | VEINES-QoL/Sym | Disease-specific quality of life measure. Standardised score, hence no meaningful min/max. High score = better quality of life. | 6 weeks, 6 months, 12 months | |
Secondary | Villalta score | Disease severity score. Min score 0, Max score 33. High score = worse severity of disease. | 6 weeks, 6 months, 12 months | |
Secondary | Ginsberg score, dichotomous outcome (Yes / No) | Diagnostic system for PTS (Yes /No). | 6 weeks, 6 months, 12 months | |
Secondary | Venous ulceration, dichotomous outcome | Presence of venous ulceration on clinical examination. | 6 weeks, 6 months, 12 months | |
Secondary | SF-36 | Quality of life measure. Standardised score, 0 - 100 per section. High score = better quality of life. | 6 weeks, 6 months, 12 months | |
Secondary | EQ-5D-5L | Quality of life measure. Scored 0 - 100 for VAS. High score = better quality of life. | 6 weeks, 6 months, 12 months | |
Secondary | Walking distance | Walking distance, metres, self-reported. | 6 weeks, 6 months, 12 months |
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