Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Clinically-driven Target Lesion Revascularization (TLR)
研究概览
简要总结
To investigate whether pre-procedural OCT-derived de novo coronary lesion phenotype (lipid-rich, fibrotic, calcific; and ACS mechanisms such as plaque rupture/erosion/calcified nodule) is associated with clinical outcomes after DCB angioplasty.
详细描述
PICCOLETO IX PHENO is an investigator-initiated, multicenter, international, ambispective (retrospective and prospective) cohort study enrolling patients who underwent DCB angioplasty for de novo coronary artery disease with preprocedural OCT assessment of the target segment. OCT images (baseline mandatory; post-preparation and post-PCI when available) and angiography will be analyzed by independent core laboratories; clinical events will be adjudicated by an independent committee. The primary endpoint is clinically-driven target lesion revascularization at 12 months; secondary endpoints include device-oriented composite endpoint (cardiac death, TLR, target-vessel MI), target vessel revascularization, MI endpoints, and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines).
- •De novo obstructive CAD: ≥50% left main stenosis, or any stenosis ≥70%, or FFR <0.80 in any other major epicardial vessel, or MLA deemed ischemic at intravascular imaging.
- •OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty.
- •Successful DCB angioplasty according to DCB ARC criteria.
- •Patients who underwent DCB-only PCI, or hybrid DCB-DES PCI with at least 20 mm of the target segment treated with DCB.
排除标准
- •Previous revascularization of the target segment with stent.
- •Hybrid DCB-DES PCI with DCB-treated segment <20 mm and/or lacking complete OCT assessment of the DCB-treated segment and/or bailout stenting.
- •Lack of at least 6 months of clinical follow up.
- •PCI of chronic total occlusion.
结局指标
主要结局
Clinically-driven Target Lesion Revascularization (TLR)
时间窗: 12 months
Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion.
次要结局
- Device-Oriented Composite Endpoint (DOCE)(12 months)
- Target Vessel Revascularization (TVR)(12 months)
- All-cause Mortality(12 months)
- Cardiac Death(12 months)
- Target-Vessel Myocardial Infarction (TV-MI)(12 months)
- Any Myocardial Infarction(12 months)