Percutaneous Coronary Intervention Clinical Trial
Official title:
A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography
This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims 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 total coronary occlusion lesion(s).
This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary
arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no
more than 10 research centers in China. All participants met the inclusion criteria will be
1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE
everolimus-eluting coronary stent.
Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented
to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months
post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The
clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5
years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months
post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent
Tomography (OCT) at 3 months post-index procedure.
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