A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Beijing Hospital
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- late lumen loss，LLL
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
A prospective, multicenter, randomized controlled, open-label, non-inferiority trial. Plan to recruit 240 patients whose lesions are de novo coronary artery disease (reference vessel diameter ≥ 3.0 mm), diameter stenosis ≥ 75% with ischemic symptoms or objective evidence of ischemia (ECG, cardionuclide, or FFR), and are suitable for implantation DES or DCB. After successful preconditioning, patients were randomly assigned to two PCI treatment groups(drug-coated balloon or drug-eluted stent) in a 1:1 ratio. The safety and efficacy of drug-coated balloons in PCI treatment of de novo coronary artery lesions (reference diameter 3.0 mm and above) were evaluated by comparing the late lumen loss of two groups of subjects in 12 months.
Investigators
Xue Yu
Vice director of cardiology department
Beijing Hospital
Eligibility Criteria
Inclusion Criteria
- •Over 18 years old;
- •Asymptomatic myocardial ischemia, stable or unstable angina;
- •The subject (or legal guardian) understands the trial requirements and treatment process, and signs a written informed consent before performing any prescribed inspection or operation;
- •Willing to undergo all follow-up evaluations requested by the trial, including admission angiographic evaluation at 12 months;
- •The target lesion must be the de novo lesion, and the diameter of the reference vessel is ≥3.0mm.
Exclusion Criteria
- •Patients with acute ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction within 3 months;
- •Hypersensitivity to the investigational balloon/stent system or concomitant medications required by the protocol;
- •Intolerant of dual antiplatelet therapy, or clinical conditions requiring long-term use of oral anticoagulants;
- •Life expectancy is less than 12 months;
- •eGFR≤30ml/min/1.73m2 or blood purification treatment;
- •LVEF≤40% or NYHA cardiac function class≥III;
- •Clinical conditions of severe hepatic insufficiency and coagulation disorder
- •Pregnant or breastfeeding women;
- •Participating in another clinical trial and have not completed the primary endpoint observation of the trial;
- •Reference lumen diameter \> 4.0mm;
Outcomes
Primary Outcomes
late lumen loss，LLL
Time Frame: 12 months after PCI
late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI
Secondary Outcomes
- target lesion failure，TLF(12 months after PCI)