Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice (PANDA-III)

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

• The patient must be ≥18 of age;
• Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable coronary artery disease, or acute coronary syndrome including non-ST-elevation and ST-elevation myocardial infarction;
• Acceptable candidate for CABG;
• The patient is willing to comply with specified follow-up evaluations;
• Patients who agree to accept the follow-up visits.
• Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
• At least one lesion with a diameter stenosis >50% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;

Exclusion Criteria:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure.
• Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
• Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin , styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
• Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.