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

NCT05622500 | Terminated DMC

• 1 other identifier: 22SM7477
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Venous Insufficiency; Chronic Venous Thrombosis; Iliac Vein Stenosis; Iliac Vein Obstruction; Post Thrombotic Syndrome

Keywords

Deep venous stenting; Intravascular ultrasound; Post thrombotic syndrome; Non-thrombotic iliac vein lesions; Proximal venous outflow obstruction; Chronic venous disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Re-intervention, number of participants requiring an additional procedure.

  6 weeks, 3 months, 6 months, 12 months

• Stent patency, dichotomous outcome, number of participants with a patent stent at last follow-up.

  6 weeks, 3 months, 6 months, 12 months

• Cost-effectiveness of deep venous reconstruction

  12 months

• VEINES-QoL/Sym

  6 weeks, 6 months, 12 months

• Villalta score

  6 weeks, 6 months, 12 months

Study Arms (2)

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

EXPERIMENTAL

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).

Procedure: Deep venous stenting; Combination Product: Best medical therapy

Best medical treatment alone (compression +/- anticoagulation).

ACTIVE COMPARATOR

The comparator arm will consist of participants receiving best medical treatment alone.

Combination Product: Best medical therapy

Interventions

Deep venous stenting PROCEDURE

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

Also known as: Deep venous reconstruction, Iliac vein stenting

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

Best medical therapy COMBINATION_PRODUCT

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.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• British Heart Foundation: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, UK, W68RF, United Kingdom

Location

Related Publications (1)

• Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

  PMID: 39968829 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Alun Davies, PhD

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor-blinded (single blind)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Superiority comparison using intention to treat analysis

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 18, 2022
• Study Start: September 3, 2022
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

GB (1)