Ultrathin sirolimus‑eluting stents with P2Y12‑only single antiplatelet therapy versus conventional dual antiplatelet therapy for left main coronary artery disease

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 randomized interventional study compares LMCA PCI using the Supraflex Cruz ultrathin‑strut biodegradable polymer sirolimus‑eluting stent followed by P2Y12 inhibitor‑based single antiplatelet therapy after a short DAPT course versus conventional dual antiplatelet therapy. Eligible patients are adults with significant unprotected left main coronary stenosis who undergo successful PCI with at least one Supraflex Cruz stent and can provide informed consent, while patients with prior CABG, need for oral anticoagulation, in‑stent restenosis/thrombosis, or recent STEMI are excluded. The trial will follow participants to capture ischemic and bleeding events, repeat revascularization, and stent‑related outcomes to determine whether the shorter/more focused antiplatelet regimen maintains safety and effectiveness in this high‑risk lesion subset. The design builds on prior ultrathin‑stent and shortened DAPT strategies but focuses specifically on unprotected LMCA PCI in a controlled randomized comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome).
* Subject with significant unprotected (ostial, mid-shaft, or distal) LMCA stenosis who underwent successful LMCA PCI with ≥1 Supraflex Cruz ultrathin-strut biodegradable polymer sirolimus-eluting stent (Sahajanand Medical Technologies Ltd., Surat, India) according to current ESC guidelines on myocardial revascularization and/or local Heart Team decision.
* Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure.

Exclusion Criteria:

* Contraindications to PCI and/or DES implantation.
* Inability to adhere to DAPT for at least 6 months.
* Patient already on DAPT.
* Patients on oral anticoagulation.
* Previous coronary artery bypass surgery.
* LMCA in-stent restenosis or stent thrombosis.
* Recent ST-elevation myocardial infarction \<5 days prior to randomization.
* Cardiogenic shock/hemodynamic instability at the time of intervention and/or need for mechanical/pharmacologic hemodynamic support.
* Participation or planned participation in another clinical trial, except for observational registries.
* Life expectancy \<1 year.
* Pregnancy.

Where it's running

• Zurich University Hospital
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Juan F. Iglesias, MD — Geneva University Hospitals, Switzerland
• Study coordinator: Maëlle Achard, RN
• Email: maelle.achard@hcuge.ch
• Phone: +41795533553

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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.