A Phase 4 interventional study of Firebird 2 sirolimus-eluting stent and Excel sirolimus-eluting stent in Coronary Artery Disease, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-15.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 570 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
the patients who receive Firebird 2 stent
Device: Firebird 2 sirolimus-eluting stent
the patients who receive Excel stent
Device: Excel sirolimus-eluting stent
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
in-stent late lumen loss at 9 months' angiographic follow-up
patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed
Time frame: 9 months
target vessel failure
defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting \[CABG\] or repeated percutaneous transluminal coronary angioplasty \[PTCA\]).
Time frame: 2 years after index procedure
This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine