Ultrathin sirolimus‑eluting stents with P2Y12‑only single antiplatelet therapy versus conventional dual antiplatelet therapy for left main coronary artery disease
ULTRATHIN-STRUT BIODEGRADABLE POLYMER SIROLIMUS-ELUTING STENTS COMBINED WITH P2Y12 INHIBITOR-BASED SINGLE ANTIPLATELET THERAPY AFTER A SHORT DUAL ANTIPLATELET THERAPY REGIMEN VERSUS CONVENTIONAL DUAL ANTIPLATELET THERAPY FOR UNPROTECTED LEFT MAIN CORONARY ARTERY DISEASE
This trial will test whether using an ultrathin‑strut sirolimus‑eluting stent followed by P2Y12‑only single antiplatelet therapy after a short period of dual therapy works as well as standard dual antiplatelet therapy for adults treated with PCI of the unprotected left main coronary artery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 828 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT05650411 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic or non‑ST‑elevation acute coronary syndromes who undergo successful PCI of an unprotected left main coronary artery lesion with at least one Supraflex Cruz ultrathin sirolimus‑eluting stent and can give informed consent are the ideal candidates.
Not a fit: Patients who require long‑term oral anticoagulation, have prior coronary artery bypass graft surgery, have LMCA in‑stent restenosis or stent thrombosis, are already on DAPT or cannot adhere to the protocol, or had a very recent STEMI are unlikely to benefit from the single‑antiplatelet approach tested here.
Why it matters
Potential benefit: If successful, patients treated for unprotected left main disease may be able to use a shorter, P2Y12‑only antiplatelet approach that preserves stent protection while reducing bleeding risk and pill burden.
How similar studies have performed: Previous all‑comer trials have shown non‑inferiority of ultrathin biodegradable‑polymer sirolimus stents versus conventional DES and separate trials have supported shortened DAPT with P2Y12 monotherapy in selected populations, but robust randomized evidence specifically for unprotected LMCA PCI is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zurich, Canton of Zurich
- 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
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.