New heart balloon shows promise in artery opening trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The patient is at least 18 to 75 years of age, male or not pregnant female. 2. Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction. 3. De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis. 4. Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm. 5. Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) \>50% with evidence of ischemia. 6. The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels. 7. Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation. 8. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent. Exclusion Criteria: 1. Evidence of ongoing acute myocardial infarction within a week. 2. Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion. 3. Severe calcification and Target lesion in a severe angulation (\> 45 degrees). 4. Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) \<40%. 5. Patient with renal dysfunction, as Cr\>176.82umol/L or Cr \>2.0 mg/dl. 6. 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. 7. Patients with allergies to heparin and contrast media. 8. Target lesion demonstrating severe dissection prior to planned deployment of the trial device. 9. Visible thrombus at the target lesion. 10. Patients received heart transplantation. 11. Participation in another clinical trial (12 months after index procedure). 12. Those who participated in another clinical trials, but did not reach the primary endpoint.