Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol

NCT07415902 | Not Yet Recruiting

• 1 other identifier: TR-0282
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary Artery Drug-Coated Balloon Dilatation Catheter; In-Stent Restenosis; De Novo Coronary Artery Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Surgical success rate

  Immediately after the treatment

• Incidence of stent thrombosis

  24 months

• Incidence of device-related cardiovascular events (DoCE)

  24 months

• Incidence of patient-related cardiovascular events (PoCE)

  24 months

• Device usage

  Immediately after the treatment

Study Arms (1)

treatment group

Coronary Artery Drug-Coated Balloon Dilatation Catheter

Device: Coronary Artery Drug-Coated Balloon Dilatation Catheter

Interventions

Coronary Artery Drug-Coated Balloon Dilatation Catheter DEVICE

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.

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Central Study Contacts

jian min tang, professor

CONTACT

+8613525571037; tjmgrx@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)