DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 21
- 主要终点
- EFFICACY: Late Lumen Loss (LLL)
研究概览
简要总结
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).
详细描述
Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.
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
- •Patients must meet all inclusion criteria:
- •Patients >18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
- •Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
- •Lesion to treat in a vessel between 2.5 and 4 mm.
排除标准
- •Patients must not meet any criteria
- •Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
- •Pregnant or breastfeeding patients.
- •Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
- •Impossibility to maintain double antiplatelet treatment during at least 1 month.
- •Life expectancy <1 year.
- •Index lesion at left main stem.
- •Aorto-ostial lesion.
- •Target lesion previously treated with stents or DEB.
- •High thrombus burden in the target lesion (TIMI thrombus scale≥3).
研究组 & 干预措施
Drug Eluting Stent (DES)
干预措施: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent (Device)
Drug Eluting Balloon (DEB)
干预措施: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon (Device)
结局指标
主要结局
EFFICACY: Late Lumen Loss (LLL)
时间窗: 9 Month
Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 9-month follow-up
EFFICACY: Net Lumen Gain (NLG)
时间窗: 9 Month
Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 9-month follow-up and MLD at the lesion site at baseline
次要结局
- SAFETY: Dissection(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Perforation(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Abrupt vessel closure(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Slow Flow(During Percutaneous Coronary Intervention (PCI))
- SAFETY: No Reflow(During Percutaneous Coronary Intervention (PCI))
- SAFETY: MACE(24 Months)
- SAFETY: Stent Thrombosis(During hospitalization)
- SAFETY: Major bleeding event(During hospitalization)
- SAFETY: Hemodynamic stability(During hospitalization)
- EFFICACY: Diameter Stenosis(Day 0)
- EFFICACY: Minimal Lumen Diammeter (MLD)(12 Months)
- EFFICACY: Crossover rate(Day 0)
- SAFETY: Myocardial Infarction(24 Months)
- SAFETY: Target Lesion Revascularization.(24 Months)
- SAFETY: Thrombosis(During Percutaneous Coronary Intervention (PCI))
- SAFETY: MACE(Up to 30 days)
- EFFICACY: Minimal Lumen Diameter (MLD)(Day 0)
- SAFETY: MACE(9 Months)
- SAFETY: MACE(12 Months)
- SAFETY: Myocardial Infarction(9 Months)
- SAFETY: Myocardial Infarction(12 Months)
- SAFETY: Cardiac death(12 Months)
- SAFETY: Target Lesion Revascularization.(9 Months)
- SAFETY: Target Lesion Revascularization.(12 Months)
- SAFETY: No Reflow(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Myocardial Infarction(24 Months)
- SAFETY: Thrombosis(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Dissection(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Perforation(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Abrupt vessel closure(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Slow Flow(During Percutaneous Coronary Intervention (PCI))
- SAFETY: Cardiac death(24 Months)
- SAFETY: MACE(24 Months)
- SAFETY: Major bleeding event(During hospitalization)
- SAFETY: Stent Thrombosis(During hospitalization)
- SAFETY: Target Lesion Revascularization.(24 Months)
- SAFETY: Hemodynamic stability(During hospitalization)
- EFFICACY: Minimal Lumen Diameter (MLD)(9 Months)
- EFFICACY: Diameter Stenosis(Day 0)
- EFFICACY: Minimal Lumen Diammeter (MLD)(12 Months)
- EFFICACY: Binary reestenosis(9 Months)
- EFFICACY: Crossover rate(Day 0)