Diagnostic Performance of 3DStent to Assess Stent Expansion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
研究概览
简要总结
The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.
The main question it aims to answer is:
The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
排除标准
- •Age <18 years
- •Coronary lesions requiring total stent length > 48 mm.
- •Body mass index >35 kg/m2
- •Uncontrolled recurrent ventricular tachycardia
- •Cardiogenic shock
- •Unable to provide written informed consent (IC).
研究组 & 干预措施
Patients undergoing PCI
Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI
干预措施: 3DStent (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of 3DStent to detect stent underexpansion with intravascular ultrasound imaging (IVUS) as a reference.
时间窗: Periprocedural timeframe
Diagnostic performance will be evaluated in terms of sensitivity and specificity. Intravascular Ultrasound (IVUS)-derived minimal stent area (MSA) ≤ 5.5 mm2 will be used to define stent underexpansion.
次要结局
- Agreement on stent expansion between 3DStent and IVUS.(Periprocedural timeframe)
- Agreement on minimal stent area (MSA) between 3DStent and Intravascular Ultrasound (IVUS).(Periprocedural timeframe)
- Impact of lesion location (vessel and segment) on 3DStent diagnostic accuracy.(Periprocedural timeframe)
- Clinical utility of 3DStent for guiding stent optimisation with Intravascular Ultrasound (IVUS) as a reference.(Periprocedural timeframe)
- Feasibility of 3DStent acquisition during the procedure(Periprocedural timeframe)
- Agreement on maximal calcium arc as assessed by 3DStent, with IVUS as the reference in cases where 3DStent is acquired pre-PCI.(Periprocedural timeframe)
- Impact of calcifications on 3DStent diagnostic accuracy.(Periprocedural timeframe)
- Agreement on stent underexpansion and MSA between site and core laboratory.(Periprocedural timeframe)
- Radiation exposure associated with 3DStent(Periprocedural timeframe)
- Procedural time of the 3DStent workflow(Periprocedural timeframe)