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NCT Number: NCT07415902

Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol

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.

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Key information

Conditions

In-Stent Restenosis or De Novo Coronary Artery Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location contact

min jian tang

CONTACT

+8613525571037

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. the incidence of Target Lesion Failure (TLF).

    Time frame: 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).

Secondary outcomes

  1. Surgical success rate

    Time frame: Immediately after the treatment

    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.

  2. Incidence of stent thrombosis

    Time frame: 24 months

    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.

  3. Incidence of device-related cardiovascular events (DoCE)

    Time frame: 24 months

    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.

  4. Incidence of patient-related cardiovascular events (PoCE)

    Time frame: 24 months

    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.

  5. Device usage

    Time frame: Immediately after the treatment

    The average number of investigational devices used per lesion and the adjuvant devices used.

Study contacts

Contact information is provided by the study sponsor or research team.

jian min tang, professor

CONTACT

[email protected]

+8613525571037

Sponsors and collaborators

Lead sponsor

DK Medical Technology (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.