Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDK Medical Technology (Suzhou) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Coronary Artery Drug-Coated Balloon Dilatation Catheter
Devicesubjects 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 groups
252 Participants
are divided into 1 treatment groupGroup A: treatment group1 intervention
Trial outcomes
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).
Time frame
24 monthsSecondary outcomes
1
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.
Time frame
Immediately after the treatment2
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.
Time frame
24 months3
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.
Time frame
24 months4
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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