Drug-coated Balloons in Big de Novo Coronary Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicentric, Randomized Controlled Clinical Trial of Drug-coated Balloons in the Treatment of Big de Novo Coronary Artery Disease

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: drug-coated balloon


Participation Criteria
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Eligibility Criteria
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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; Branch vessels ≥ 2.0 mm in diameter that may require intervention in the target lesion; The vessel where the target lesion is located has an independent lesion with a diameter stenosis of ≥50% and requires interventional therapy; Chronic total occlusive disease; Left main stem disease; Severe calcification, tortuous blood vessels, existing dissection or severe thrombus burden, the investigator judges that DCB is not suitable for treatment of lesions; Lesions with failed preprocessing, or lesions whose length exceeds the length of a single DES/DCB need to be covered after preprocessing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB treatment<br>drug-coated balloon in PCI | Device: drug-coated balloon<br>* drug-coated balloon in big de novo coronary disease<br>* Other names: drug-eluted stent;|
| Other: DES treatment<br>drug-eluted stent in PCI | Device: drug-coated balloon<br>* drug-coated balloon in big de novo coronary disease<br>* Other names: drug-eluted stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss，LLL | late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI | 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion failure，TLF | Cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization or target vessel revascularization | 12 months after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-coated balloon, de novo coronary disease