Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary Artery Drug-Coated Balloon Dilatation Catheter.
- Who it may be relevant to
- Registry conditions: In-Stent Restenosis or De Novo Coronary Artery Lesions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
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.
Primary outcome measures
- the incidence of Target Lesion Failure (TLF). [Time frame: 24 months]
Secondary outcome measures (5)
- Surgical success rate [Time frame: Immediately after the treatment]
- Incidence of stent thrombosis [Time frame: 24 months]
- Incidence of device-related cardiovascular events (DoCE) [Time frame: 24 months]
- Incidence of patient-related cardiovascular events (PoCE) [Time frame: 24 months]
- Device usage [Time frame: Immediately after the treatment]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07415902 · TR-0282