This study is a prospective, multi-center, non-inferior, randomized controlled clinical trial, aims to use optical Coherence tomography to observe the the early- and mid-stage vessel repair and neointimal proliferation. And to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ST-elevation myocardial infarction (STEMI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries. Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
Xijing Hospital
Xi’an, Shanxi, China
RECRUITINGNeointimal thickness by OCT
Time frame: At 6 months post-index procedure
Percentage of Uncovered Struts by OCT
Time frame: At 6 months post-index procedure
Target lesion failure
Time frame: 30 days, 6 months, 12 months post-index procedure
Percentage of Malaposition Struts by OCT
Time frame: At 6 months post-index procedure
Thrombosis (from ARC definition)
Time frame: 30 days, 6 months, 12 months post-index procedure
In-stent and in-segment late lumen loss
Time frame: At 6 months post-index procedure
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