Coronary Atherectomy System in Patients With Coronary Calcification (CORECT) (NCT05447585) | Clinical Trial Compass
CompletedNot Applicable
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
China239 participantsStarted 2022-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<= 4.0 mm.
AI3. The target vessel must be with a stenosis of \>= 70% and \< 100%Target lesion angiographic stenosis, or of \>=50% and \<70% with local ischemic symptoms.
AI4. Target lesion length ≤ 40 mm .
AI5. The target lesion must have evidence of severe calcium deposit, or moderate calcification which cannot be fully expanded by PTCA balloon catheter at the lesion site based on the protocol criterion, .
Clinical Exclusion Criteria:
CE1. Acute myocardial infarction wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FIM phase: Clinical success
Timeframe: During hospitalization (up to 7 days after baseline procedure).
2
RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)