Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
研究概览
简要总结
Even with second generation drug eluting stents, rates of target lesion failure (TLF) for aorto-ostial RCA lesions remain high [3yrs TLF 14.2%]. Retrospective studies show that stent underexpansion and geographical stent-ostium mismatch are the main predictors for TLF. Geographical mismatch means that the stent is implanted either too distal (thereby not fully covering the lesion) or too proximal (thereby protruding too much in the aorta and hampering future engagement with guiding catheters). The investigators hypothesize that, pre-procedural 3D CT coronarography to determine the optimal C-arm angle of the X-ray system with the most accurate visualization of the aorto-ostial angle and determination of localization of calcium, could prevent geographical mismatch.
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
- Single (Outcomes Assessor)
盲法说明
The assessor of the IVUS images will be blinded to treatment arm
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
- •Clinically indicated non-emergent PCI for an aorta-ostial-RCA lesion defined as a significant de novo lesion [by angiography or by physiological assessment] for which the operator intends to fully cover the ostial RCA with stent struts
- •Willing to provide informed consent
排除标准
- •Emergent PCI indication: if the ostial RCA lesion is the culprit lesion of an acute coronary syndrome [of note: if the ostial RCA lesion is a non-culprit lesion, patient can be included in the trial]
- •In-stent restenosis or thrombosis in the ostial RCA
- •Renal insufficiency [eGFR<30 ml/min]
- •Known allergic reaction to contrast medium
结局指标
主要结局
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
时间窗: Procedural
Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).
次要结局
- Procedural radiation dose(Procedural)
- Volume of contrast agent administered(Procedural)
- Minimal luminal area (MLA)(Procedural)
- Calcified lesions(Procedural)
- Procedural duration from first puncture of artery to skin closure(Procedural)
- Stent expansion(Procedural)
- Stent sizing(Procedural)
- Calcium modification(Procedural)
- MACCE at 30 days follow-up(30 days after PCI)
- Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)(Procedural)
研究者
Koen Ameloot
Interventional cardiologist
Ziekenhuis Oost-Limburg