Clinical Trial

Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07415902
Lead Sponsor DK Medical Technology (Suzhou) Co., Ltd.
Conditions In-Stent Restenosis or De Novo Coronary Artery Lesions
Enrollment 252 participants
Start Date 2026-02-28
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-17