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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.
Details
| Lead sponsor | DK Medical Technology (Suzhou) Co., Ltd. |
|---|---|
| Status | NOT_YET_RECRUITING |
| Enrolment | 252 |
| Start date | 2026-02-28 |
| Completion | 2028-12 |
Conditions
- In-Stent Restenosis or De Novo Coronary Artery Lesions
Interventions
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
Primary outcomes
- the incidence of Target Lesion Failure (TLF). — 24 months
The percentage of subjects who experience TLF from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI), and clinically driven target lesion revascularization (CD-TLR).
Countries
China