Comparing two strategies for treating coronary bifurcation lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Catharina Hospital
  Eindhoven, North Brabant, Netherlands Recruiting

Study contacts

• Study coordinator: Koen Teeuwen, MD, PhD
• Email: koen.teeuwen@catharinaziekenhuis.nl
• Phone: 040- 2398360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.