Drug-coated Balloons in Big de Novo Coronary Disease

Not Applicable

Recruiting

• Conditions: Coronary Heart Disease
• Interventions: Device: drug-coated balloon

• Registration Number: NCT05550233
• Lead Sponsor: Beijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES treatment	drug-coated balloon	drug-eluted stent in PCI
DCB treatment	drug-coated balloon	drug-coated balloon in PCI

Primary Outcome Measures

Name	Time	Method
late lumen loss，LLL	12 months after PCI	late lumen loss in target lesions obtained by coronary angiography at 12 months after PCI

Secondary Outcome Measures

Name	Time	Method
target lesion failure，TLF	12 months after PCI	Cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization or target vessel revascularization

Trial Locations

Locations (1)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China