NCT07415902

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 252 (estimated)
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• In-Stent Restenosis or De Novo Coronary Artery Lesions

Interventions

Type	Name	Description
DEVICE	Coronary Artery Drug-Coated Balloon Dilatation Catheter	subjects who have received coronary artery drug-coated balloon dilatation catheter treatment in the selected centers for a period of time since the product's marketing will be screened one by one in accordance with the inclusion and exclusion criteria. During the process, data collection will be conducted by direct medical history collection or reviewing medical records in the medical record system of each center.

Timeline

• Start date: 2026-02-28
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China