Comparing two strategies for treating coronary bifurcation lesions
Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy. A Randomized Controlled Trial and Registry
This study is testing whether a new treatment using drug-eluting balloons is better than a two-stent approach for people with specific heart artery blockages to see which method helps them more and has fewer problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cathreine BV Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT05731687 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a hybrid approach using drug-eluting balloons versus a stepwise provisional two-stent strategy for treating coronary bifurcation lesions. The study aims to determine which method provides better outcomes while minimizing complications and costs associated with the procedure. Participants will include patients with significant bifurcation lesions who are stable and eligible for drug-eluting stent treatment. The trial seeks to address ongoing debates in the optimal management of these complex lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant de novo bifurcation lesions and stable coronary artery disease.
Not a fit: Patients with unstable clinical conditions or those who have previously undergone PCI with stent implantation in the target lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary bifurcation lesions, potentially reducing complications and healthcare costs.
How similar studies have performed: Several small pilot studies have shown success with similar approaches, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Significant de novo bifurcation lesion (main vessel and side branch diameter ≥ 2.5mm, diameter stenosis of the main vessel ≥ 70% and of the side branch ≥ 50% or in intermediate stenosis FFR ≤ 0.80 or iFR ≤ 0.89) * Stable coronary artery disease or stabilized acute coronary syndrome * Age ≥ 18 years * Acceptable candidate for treatment with a drug eluting stent Exclusion Criteria: * Unstable clinical condition * Previous PCI with stent implantation in the target lesion(s) * Known comorbidity with a life expectancy of \<2 year * Active bleeding requiring medical attentions (BARC \>2 at index PCI) * Pregnancy * Unable to provide consent for any other reason * Participation in another stent or drug trial * Known hypersensitivity or allergy for asprin, clopidogrel, ticagrelor, prasugrel, cobalt chromium, sirolimus, to excipients with phospholipid or related origins.
Where this trial is running
Eindhoven, North Brabant
- Catharina Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
Study contacts
- Study coordinator: Koen Teeuwen, MD, PhD
- Email: koen.teeuwen@catharinaziekenhuis.nl
- Phone: 040- 2398360
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.