Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol

A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions

This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.

Inclusion Criteria:

• Age: ≥18 years old, regardless of gender;
• Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;
• Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.

Exclusion Criteria:

• Residual stenosis >30% after pre-treatment with type C or higher dissection;
• A history of cardiogenic shock;
• Severe congestive heart failure or NYHA class IV severe heart failure;
• Pregnant or lactating women;
• Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).