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.

Study Overview

• Status: Not yet recruiting
• Conditions: In-Stent Restenosis or De Novo Coronary Artery Lesions
• Intervention / Treatment: Device: Coronary Artery Drug-Coated Balloon Dilatation Catheter

• Study Type: Observational
• Enrollment (Estimated): 252

Contacts and Locations

• Study Contact: Name: jian min tang, professor; Phone Number: +8613525571037; Email: tjmgrx@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
      • Contact: min jian tang; Phone Number: +8613525571037

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

treatment group; Coronary Artery Drug-Coated Balloon Dilatation Catheter

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of Target Lesion Failure (TLF).	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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	The percentage of subjects with successful surgery among the total number of subjects. Surgical success is defined as visual residual stenosis diameter ≤30% at the target lesion after PCI, TIMI flow grade 3 (visual assessment), and no rescue stent implantation required.	Immediately after the treatment
Incidence of stent thrombosis	The percentage of subjects with all stent thrombosis events meeting the ARC criteria (including definite and probable) from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects.	24 months
Incidence of device-related cardiovascular events (DoCE)	The percentage of subjects with device-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The device-related clinical composite cardiovascular endpoint is defined as cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.	24 months
Incidence of patient-related cardiovascular events (PoCE)	The percentage of subjects with patient-related cardiovascular events from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. The patient-related clinical composite cardiovascular endpoint is defined as all-cause death, all myocardial infarctions, and any repeat revascularization.	24 months
Device usage	The average number of investigational devices used per lesion and the adjuvant devices used.	Immediately after the treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: In-Stent Restenosis; Coronary Artery Drug-Coated Balloon Dilatation Catheter; De Novo Coronary Artery Lesions
• Other Study ID Numbers: TR-0282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No