Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions

Inclusion criteria

Clinical inclusion criteria

• Patients with an indication for PCI due to acute or chronic coronary syndrome
• Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up

Angiographic inclusion criteria

• De novo lesion(s)
• Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)
• Target lesion is NOT

• Severely calcified
• In-stent restenosis
• Diffused lesion requiring stent overlapping or more than one stent
• Located in the left main, aorto-ostial, proximal LAD/LCX/RCA involving vessel ostia (stent coverage required within 3 mm of vessel ostia), surgical graft, myocardial bridge, or chronic total occlusion
• Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter
• Located in the target vessel with severe tortuosity

Exclusion criteria

• Age < 18 years, or > 75 years
• Patient is a woman who is pregnant or nursing
• Patients who have received any stent implantation in the target vessel within one year
• Patients required long-term oral anticoagulation
• Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk
• Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast
• Currently participating in another trial and not yet at its primary endpoint
• Patients whose life expectancy is less than 3 years
• Cardiogenic shock