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Completed
NCT05447585
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
Conditions: Calcification of Coronary Artery
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 239
Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.
Location: The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
Summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
Eligibility Criteria
Clinical Inclusion Criteria:
CI1. Age between 18 and 80.
CI2. Subjects who are going to accept percutaneous coronary intervention (PCI) and drug-eluting stent implantation.
CI3. Asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
CI4. Acceptable candidates for coronary artery bypass grafting (CABG).
CI5. The left ventricular ejection fraction (LVEF) is equal to or greater than 30% measured by echocardiography or left ventricle contrast examination within 30 days before inclusion.
CI6. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
Angiography Inclusion Criteria:
AI1. There is only one target lesion that needs to be treated.
AI2. The target vessel must be a native coronary artery with reference diameter \>= 2.5mm and \= 70% and \< 100%Target lesion angiographic stenosis, or of \>=50% and \
Source: ClinicalTrials.gov (NCT05447585). StuddyBuddy aggregates publicly available trial information.