Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery… (NCT05509296) | Clinical Trial Compass
CompletedNot Applicable
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
China136 participantsStarted 2022-09-20
Plain-language summary
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Who can participate
Age range
18 Years – 75 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.
Inclusion criteria
. The patient is at least 18 to 75 years of age, male or not pregnant female.
. Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
. Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) \>50% with evidence of ischemia.
. The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
. Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Exclusion criteria
. Evidence of ongoing acute myocardial infarction within a week.
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
Number of Device Procedural Success(Lesions Level)
. Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
. Severe calcification and Target lesion in a severe angulation (\> 45 degrees).
. Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) \<40%.
. Patient with renal dysfunction, as Cr\>176.82umol/L or Cr \>2.0 mg/dl.
. Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
. Patients with allergies to heparin and contrast media.
. Target lesion demonstrating severe dissection prior to planned deployment of the trial device.