Clinical trial

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

Name

22SM7477

Description

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).

Trial arms

Trial start

2022-09-03

Estimated PCD

2025-11-01

Trial end

2026-05-01

Status

Recruiting

Treatment

Deep venous stenting

Endovascular reconstruction encompasses balloon venoplasty and venous stenting. A dedicated venous stent will be used, the brand of which the individual interventionist will decide.

Arms:

Best endovenous reconstruction + best medical treatment (compression +/- anti-thrombotic therapy).

Other names:

Deep venous reconstruction, Iliac vein stenting

Best medical therapy

Compression stockings encompass a range of therapies used to provide an externally applied graduated-pressure up the length of the limb aiming to improve venous function and decrease lower limb swelling. Compression stockings can be classified by size and grade, i.e. the pressure the stockings applies to the limb. For the purpose of this trial Class II and Class III graduated compression stockings should be used, with the aim of providing Class III if tolerated. Antithrombotic agents include, but are not limited to: warfarin (titrated to international normalised ratio, INR), apixaban, rivaroxaban, aspirin, and clopidogrel.

Arms:

Best endovenous reconstruction + best medical treatment (compression +/- anti-thrombotic therapy)., Best medical treatment alone (compression +/- anticoagulation).

Size

328

Primary endpoint

Venous Clinical Severity Score (VCSS) at 6 months

6 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Superiority comparison using intention to treat analysis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Assessor-blinded (single blind)', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 328, 'type': 'ESTIMATED'}}

Updated at

2024-03-12

1 organization

1 product

5 indications

Organization

Imperial College London

Product

Best medical therapy

Indication

Chronic Venous Insufficiency

Indication

Venous Thrombosis

Indication

Iliac Vein Stenosis

Indication

Iliac vein obstruction

Indication

Post-thrombotic syndrome