Clinical trial NCT02017275: Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice
Official title: A Prospective, Multicenter, RAndomized, CoNtrolled, Study Comparing the Safety and Efficacy Between BuMA eG Based BioDegradable Polymer Stent and EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "ReAl-World" Practice (PANDA-III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 2348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target lesion failure (a composite of cardiac death, target lesion myocardial infarction and ischemia driven target lesionsrevascularization TLR) at 1 year
timeFrame: 12 months after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science
name: Runlin Gao, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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