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 range18 Years – 75 Years
SexALL
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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.
✕. 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).
What they're measuring
1
Number of Device Procedural Success(Lesions Level)
✕. 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.