Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting/scoring/OPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.
详细描述
PICCOLETO XI A-PREP is an investigator-initiated, multicenter, international, observational study evaluating the impact of lesion preparation strategies on outcomes following drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).
In-stent restenosis remains a clinically relevant challenge despite advances in drug-eluting stent technology and contemporary percutaneous coronary intervention techniques. DCB represents a stentless therapeutic strategy for ISR treatment, with the advantage of avoiding implantation of additional metallic layers.
A key determinant of clinical outcomes in ISR, particularly with DCB angioplasty, is the adequacy of lesion preparation before definitive therapy. Effective preparation facilitates optimal drug delivery, improves luminal gain, and may reduce the risk of recurrent restenosis.
A large spectrum of balloon-based modalities is available for ISR lesion preparation, ranging from semi-compliant and non-compliant balloons to more aggressive tools such as scoring and cutting balloons. Although more aggressive devices may enhance plaque modification and neointimal tissue disruption, their incremental clinical benefit over standard approaches remains uncertain.
Patients will be categorized into two groups based on lesion preparation strategy:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients ≥18 years of age
- •Patients who underwent DCB angioplasty for in-stent restenosis
排除标准
- •- Lack of clinical outcome assessment
研究组 & 干预措施
Aggressive Lesion Preparation
Patients who underwent lesion preparation using cutting/Wolverine balloons, scoring balloons (any brand), and/or OPN balloons prior to DCB angioplasty for ISR.
Standard Lesion Preparation
Patients who underwent lesion preparation using semi-compliant balloons and/or non-compliant balloons prior to DCB angioplasty for ISR.
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 12 months
Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).
次要结局
- Cardiac Death(12 months and longest available follow-up)
- Non-fatal Myocardial Infarction(12 months and longest available follow-up)
- Target Lesion Revascularization (TLR)(12 months and longest available follow-up)
- Target Vessel Myocardial Infarction (TV-MI)(12 months and longest available follow-up)
- BARC Major Bleeding(12 months and longest available follow-up)
- Procedural Success(At procedure)
- Post-procedural Diameter Stenosis(At procedure)
- Angiographic Dissection(At procedure)
- TIMI Flow Grade(At procedure)