The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Coronary Flow Reserve (CFR)
研究概览
简要总结
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation. We will enroll 30 conveniently sampled subjects assigned to one of three therapeutical methods lithotripsy, super-high pressure balloon, and orbital atherectomy prior to implantation of drug-eluting stents (DES).
详细描述
This prospective, non-randomized, single-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. 30 patients with severe coronary stenosis will be enrolled. The severity will be assessed by Optical Coherence Tomography (OCT) based on the degree of calcification in the coronary lesion as defined by this protocol. Subjects will be assigned to one of three arms (lithotripsy, super-high pressure balloon or orbital atherectomy) followed by an implantation of drug-eluting stents (DES). The aposition and expansion of DES will be evaluated using OCT . Patients will be followed through discharge, 30 days and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects with native coronary artery disease (including stable or unstable angina and NSTEMI) suitable for PCI.
- •The lesion must be crossable with the study guide wire.
- •The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm.
- •The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion.
- •Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.
- •Male or female, age above or equal to 18 years at the time of signing informed consent.
- •Further inclusion criteria may apply
排除标准
- •Inability to understand the study or a history of non-compliance with medical advice.
- •Unwilling or unable to sign the Informed Consent Form (ICF).
- •History of any cognitive or mental health status that would interfere with trial participation.
- •Male or female, age under 18 years at the time of signing informed consent.
- •Female subjects who are pregnant or planning to become pregnant within the study period.
- •Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Subject has evidence of an active infection on the day of the procedure requiring oral or intravenous antibiotics.
- •Limited long term prognosis due to other conditions.
- •Subjects in cardiogenic shock or with decompensated heart failure (NYHA class IV).
- •Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR <30).
- •Most recent left ventricular ejection fraction ≤ 20%.
- •Subject is an acceptable candidate for coronary artery bypass surgery.
- •The target vessel reference diameter is under 2.0 mm.
- •Target lesion is located in or supplied by an arterial or venous bypass graft.
- •The target vessel has angiographically visible or suspected thrombus.
- •The target lesion is in an in-stent restenosis.
- •Subject has received a heart transplant.
- •Subject has major valve disease and underwent intervention within 30 days prior to randomization.
- •Further exclusion criteria may apply
结局指标
主要结局
Coronary Flow Reserve (CFR)
时间窗: Intraprocedural
Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Index of Microcirculatory Resistance (IMR)
时间窗: Intraprocedural
Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
次要结局
- Strategy Success(Intraprocedural)
- Stent expansion(Intraprocedural)
- Acceptable stent expansion(Intraprocedural)
- Optimal stent expansion(Intraprocedural)
- Minimal lumen diameter (MLD) difference(Intraprocedural)
- Procedural Success(Up to 3 years)