Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 656
- 主要终点
- Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.
研究概览
简要总结
The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:
- Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).
- Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
- Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.
Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR >0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.
详细描述
Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.
Definite or probable thrombosis in DCB or DES treated vessels will be documented.
After randomization, if a dissection with restricted blood flow occurs after DCB treatment, DES will be implanted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Moderate to severe calcified lesions assessed by coronary angiography
- •In situ coronary artery calcification
- •Target lesion with indications for coronary intervention
- •Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm
- •Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).
- •QFR > 0.8 after calcification modification
排除标准
- •Patients with ST-segment elevation myocardial infarction:
- •Patients with renal failure requiring dialysis or currently undergoing dialysis.
- •Patients whose coronary angiography quality is unsuitable for QFR analysis.
- •Patients with in-stent restenosis.
- •⑤ Patients with other medical conditions and a life expectancy of <1 year.
- •⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.
- •⑦ Patients who cannot tolerate dual antiplatelet therapy.
- •⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.
- •⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.
- •⑩ Patients currently participating in another clinical trial for coronary interventional devices.
结局指标
主要结局
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.
时间窗: One year after treatement.
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.
时间窗: One year after treatement.
次要结局
- Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.(From treatment to hospital discharge)
- QFR at one year post PCI(one year after treatment)
- Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.(From treatment to hospital discharge)
- QFR at one year post PCI(one year after treatment)
研究者
Junbo Ge
Professor of Medicine/Cardiology and Director of the Department of Cardiology at Zhongshan Hospital, Fudan University,Chairman of the Shanghai Institute of Cardiovascular Diseases.
Shanghai Zhongshan Hospital