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Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol

NCT07415902 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 252

Last updated 2026-02-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • DK Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415902 on ClinicalTrials.gov