Calcium Reduction by Orbital Atherectomy in Western Europe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary imaging endpoint
研究概览
简要总结
In calcified lesions, optimal stent placement and expansion may prove to be challenging. Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for which orbital atherectomy can used. Therefore the aim of this study is to:
- Show that orbital atherectomy effectuates optimal stent expansion
- Investigate the mechanics of lesion preparation when using orbital atherectomy
Patients presenting with a significant and severely calcified lesion in need of orbital atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent placement.
详细描述
The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc., St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to facilitate stent delivery in patients with severely calcified coronary artery disease (CAD). As of to date, detailed sequential intravascular imaging data unraveling the exact calcium modifying effect of orbital atherectomy (OA) prior to stent placement in vivo, are lacking.
The aim of this, international, multicenter, prospective and observational single arm study is to understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions priot to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area. The study population consists of patients undergoing percutaneous coronary intervention of a severely calcified coronary lesion in need of OA to enable proper stent placement and expansion.
A total of 100 patients will be enrolled. All patients will undergo peri-procedural imaging using OCT and the aim is to obtain data for at least 50 patients with OCT before and after OA and after stenting.
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
- •De novo significant native coronary artery lesion
- •The target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen protruding calcified nodules at >1 cross section by intravascular imaging (OCT)
- •The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length
排除标准
- •Left main disease
- •Prior stenting of the target vessel
- •Target lesion has thrombus or dissection
- •Known left ventricular ejection fraction LVEF ≤ 25%
- •Diagnosed with chronic renal failure (GFR < 30 ml/min)
- •Confirmed pregnancy
- •Life expectancy < 12 months
- •Coronary anatomy that prevents delivery of OCT catheter
- •Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide
结局指标
主要结局
Primary imaging endpoint
时间窗: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA
次要结局
- Target vessel failure (TVF)(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months)
- Intracoronary imaging endpoints on OCT(Periprocedure)
- minimal luminal diameter Diameter on angiography(Periprocedure)
- Major intraprocedural complications(Periprocedure)
- Probable and definite stent thrombosis(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months)
- Procedural success(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Major adverse cardiac events (MACE)(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months)
- MSA on OCT(Periprocedure)
- Stent expansion on OCT(Periprocedure)
- Calcium and fractures on OCT(Periprocedure)
- Hematoma on OCT(Periprocedure)
- Individual components of MACE and TVF(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months)
- Periprocedural myocardial infarction(Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Diameter stenosis on angiography(Periprocedure)
- Acute gain Diameter on angiography(Periprocedure)
研究者
Wijnand den Dekker
Interventional Cardiologist
Erasmus Medical Center