Evaluate the Clinical Efficacy and Safety of Non-Compliant PTCA Balloon Dilatation Catheter

This study is designed as a retrospective, multicenter, real-world study. A total of 200 patients with coronary heart disease who were consecutively admitted to three centers between January 2026 and March 2026, treated with the NC PTCA balloon catheter, and had complete case information will be enrolled. The primary endpoints are device success rate and procedure success rate, and the secondary endpoints are major adverse cardiovascular events (MACE), target lesion failure (TLF), all-cause death, and myocardial infarction in-hospital.

• balloon angioplasty (Device): The balloon catheter expands a stenotic portion of the coronary artery or bypass graft during percutaneous transluminal coronary angioplasty (PTCA). The balloon catheter can be used for post-delivery expansion of balloon expandable stents.

Primary outcomes

• Device Success Rate [immediate post-intervention]: The balloon successfully reached and crossed the target lesion, was successfully inflated, deflated, and withdrawn back into the guide catheter.
• Procedural Success Rate [immediate post-intervention]: Device success, with no device-related adverse events occurring during the inflation process.

Secondary outcomes

• Major Adverse Cardiovascular Events (MACE) during hospitalization [during hospitalization, 3-7 days post-procedure]: A composite of cardiac death, myocardial infarction, or target lesion revascularisation (TLR)
• Target Lesion Failure (TLF) during hospitalization [during hospitalization, 3-7 days post-procedure]: A composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (CD-TLR)
• All-cause mortality during hospitalization [during hospitalization, 3-7 days post-procedure]: The proportion of patients who died during the in-hospital until discharge
• Any myocardial infarction during hospitalization [during hospitalization, 3-7 days post-procedure]: The proportion of patients who develop any myocardial infarction during the in-hospital until discharge

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years.
* Presence of a stenotic lesion in a native coronary artery or bypass graft suitable for percutaneous coronary intervention (PCI).
* The patient voluntarily received NC PTCA treatment (pre-dilation before stent implantation and/or post-dilation after stent implantation).

Exclusion Criteria:

* Known contraindications to the investigational device as specified in the product instructions for use.
* Incomplete case information that would affect the evaluation of the primary endpoints.

• Wenhua Lin, Principal investigator, TEDA International Cardiovascular Hospital