Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Stent expansion
研究概览
简要总结
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.
详细描述
Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting CNs, identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).
Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).
Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.
Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.
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
- None
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
- •Patients aged ≥ 18 years.
- •Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
- •Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation*.
- •Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. * Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.
排除标准
- •Culprit lesions in acute coronary syndrome with ST elevation.
- •Left main disease.
- •In-stent restenosis lesions.
- •Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.
- •Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
- •Cardiogenic shock.
- •Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
- •Life expectancy of less than one year.
- •Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
- •Coronary artery disease with an indication for surgical revascularization.
- •Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
- •Inability to obtain informed consent.
- •Allergy to eggs or soy, contraindicating the use of OA.
结局指标
主要结局
Stent expansion
时间窗: At the end of percutaneous coronary intervention
Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas.
次要结局
- Procedural success(At the end of percutaneous coronary intervention)
- Strategy success(At the end of percutaneous coronary intervention)
- Minimum stent area(At the end of percutaneous coronary intervention)
- Minimum stent area at the CN site.(At the end of percutaneous coronary intervention)
- Significant stent malapposition at the CN site(At the end of percutaneous coronary intervention)
- Degree of calcium nodule debulking(At the end of percutaneous coronary intervention)
- Evidence of fracture at the CN site(At the end of percutaneous coronary intervention)
- Degree of stent ellipticity at the CN site(At the end of percutaneous coronary intervention)
- Residual luminal protrusion of the calcium nodule following stent implantation(At the end of percutaneous coronary intervention)
- Target lesion failure (TLF) at 12 months(At 12 months)
- Target lesion revascularization (TLR) at 12 months(At 12 months)
- Major Adverse Cardiovascular Events (MACE) at 12 months(At 12 months)
研究者
Luis Manuel Domínguez Rodríguez
Interventional Cardiologist and Clinical Researcher
Spanish Society of Cardiology