Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice
Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice
PANDA III is sought to investigate the safety and efficacy of a PLGA-polymer with
 electro-grafting base layer sirolimus-eluting stent (SES) versus a PLA-polymer SES at 12
 months follow-up.
The BuMA stent (SINOMED, Beijing, China) was a novel biodegradable PLGA polymer
 sirolimus-eluting stent (SES), with design of adding an electro-grafting (eG) base layer
 between the polymer and the stainless steel stent strut.The eG layer can secure adhesion of
 the biodegradable PLGA coating as a result of the interdigitation, and the PLGA coating
 ensures 100% drug release within 30 days.The initial investigation showed a high strut
 coverage rate in both the BuMA stent and the Xience V stent at 3 months follow-up. Moreover,
 earlier vascular healing after drug-eluting stent implantation may reduce the incidence of
 stent thrombosis at follow-up and potentially shorten dual antiplatelet therapy duration.
 Therefore, we performed this randomized trial to investigate 12 months target lesion failure
 between the BuMA and the EXCEL stent, both with same eluted drug sirolimus, however different
 biodegradable polymer carriers.
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.