A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Efficacy of Biolimus Drug-Coated Balloon (DCB) Versus Drug-Eluting Stent (DES) in the Treatment of De Novo Coronary Artery Lesions
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: Biolimus-Coated Coronary Artery Balloon Dilatation Catheter, Xinyue Drug-Coated Stent System.
- Who it may be relevant to
- Registry conditions: Patients With de Novo Coronary Artery Lesions. Basic parameters: 18 years — 80 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
Interventions
- Device Biolimus-Coated Coronary Artery Balloon Dilatation Catheter
A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter. - Device Xinyue Drug-Coated Stent System
A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossal™ Xinyue Drug-Coated Stent System.
Primary outcome measures
- Primary endpoint [Time frame: Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure.]
Eligibility criteria
General Inclusion Criteria:
- Patients aged ≥ 18 years and ≤ 80 years;
- Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence;
- Patients without contraindications to coronary revascularization (PCI or CABG);
- Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol.
Angiographic Inclusion Criteria:
- The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).
- All target lesions shall meet the following requirements:
① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm;
② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence;
③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.
- Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
- If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07582250 · JWBA9DES-202601