Comparing drug-coated balloons to stenting for coronary artery treatment
A Randomized, Multi-center, Non-inferiority Clinical Trial on the Treatment of Residual Disease With Drug-Coated Balloon After Successful Recanalization and Limiting Stenting to the CTO Body Compared to Complete Stenting of the CTO Body and Adjacent Residual Disease.
This study is testing if drug-coated balloons can work as well as traditional stents for treating blocked coronary arteries in patients with chronic total occlusion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Amsterdam, Noord-Holland and 1 other locations) |
| Trial ID | NCT04881812 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of drug-coated balloons (DCB) compared to traditional stenting in patients with chronic total occlusion (CTO) of the coronary artery. It is a randomized, multi-center, non-inferiority trial where patients eligible for percutaneous coronary intervention (PCI) will receive either DCB treatment or complete stenting for adjacent residual disease after successful recanalization of the CTO. The study aims to determine if DCB treatment can provide similar outcomes to stenting while potentially reducing complications associated with longer stent lengths.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical indication for revascularization of a chronic total occlusion as determined by a local heart team.
Not a fit: Patients with significant coronary complications, such as acute coronary syndrome or severe kidney disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients undergoing treatment for chronic total occlusions.
How similar studies have performed: While the use of drug-coated balloons has shown promise in other contexts, data specifically regarding their use in chronic total occlusions is currently lacking, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Clinical indication for revascularization of the CTO as determined by the local heart team (based on symptoms, documented ischemia, and viability) * Successful recanalization of the CTO with residual disease adjacent to the initial lesion Exclusion Criteria: * Dissection affecting the flow (TIMI score\<3), significant recoil (\>30%) or coronary perforation after predilation * Reference diameter of the vessel is \<2.5 mm or \>4.0 mm * Bifurcation lesion requiring the stenting of the side branch * Left main lesion * Acute coronary syndrome * Cardiogenic shock * Severe kidney disease defined as an eGFR \< 30 ml/min * Pregnancy * Life expectancy \< 12 months * Inability to give written consent
Where this trial is running
Amsterdam, Noord-Holland and 1 other locations
- VUmc — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Amsterdam Medical Center — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Paul Knaapen, MD PhD — Amsterdam UMC, location VUmc
- Study coordinator: Yvemarie Somsen, MD
- Email: y.somsen@amsterdamumc.nl
- Phone: +312 (0)444 3272
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.