Comparing endovenous treatment with standard therapy for chronic venous disease
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease - the BEST Multi-centre Randomised Controlled Trial
NA · Imperial College London · NCT05622500
This study is testing if a new endovenous treatment can help adults with chronic venous disease feel better compared to the usual therapy they receive.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (London, UK) |
| Trial ID | NCT05622500 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of best endovenous therapy, including venoplasty and deep venous stenting, compared to standard therapy for adults suffering from chronic venous disease due to post-thrombotic syndrome or non-thrombotic iliac vein lesions. Participants will be randomly assigned to one of the two treatment groups, and the primary outcome will be assessed using the Venous Clinical Severity Score at six months. The study aims to provide clearer evidence on the benefits of venous stenting in managing chronic venous conditions.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic venous disease classified as CEAP C3 to C6, resulting from proximal deep venous disease.
Not a fit: Patients who are anatomically unsuitable for stenting or have contraindications to anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with chronic venous disease, potentially reducing symptoms and complications.
How similar studies have performed: While the use of venous stenting is increasing, there is limited evidence from previous studies to support its efficacy, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, UK
- Imperial College Healthcare NHS Trust — London, UK, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Alun Davies, PhD
- Email: BESTtrial@imperial.ac.uk
- Phone: 0208 3311 7320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Venous Insufficiency, Chronic Venous Thrombosis, Iliac Vein Stenosis, Iliac Vein Obstruction, Post Thrombotic Syndrome, Deep venous stenting, Intravascular ultrasound, Post thrombotic syndrome