Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Treatment||firehawk biodegradable polymer rapamycin-eluting stent|
|Sponsor||MicroPort Medical (Shanghai) Co. Ltd.|
|Start date||August 2011|
|End date||February 2013|
|Trial size||995 participants|
|Trial identifier||NCT01412164, TARGET II|
The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
Using FIREHAWK DES treating CAD
Device related cardiovascular composite endpoint
time frame: 12 months
Stent implantation success rate
time frame: 5 years
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Age 18-75, male or unpregnant women - Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI - Native coronary artery target lesion - Target lesion length <=60mm, target lesion vessel diameter 2.25mm-4.0mm - Target lesion diamter stenosis>=70% - For each target lesion, Firehawk stent implantation only - Understand the study purpose, willing to participate and sign the letter of consent - Acceptance of clinical follow-up Exclusion Criteria: - Actue MI within 72 hours - Unprotected LM and intervention-required three-vessel lesions - Calcified lesion failed in pre-dilation and twisted lesion - Bridge vessel lesion - Any stent implanted within one year - Severe heart failure (HYHA>=III) or LVEF<40% - Renal deficiency, blood creatinine > 2.0mg/dl - Bleeding tendency - Allergic to aspirin, clopidogrel, ticlopidine, dye, ramapycin and metal - Life expectation <12 months - History of not achieving study finish - No compliances to the protocol - Heart implantation subjects
|Official title||A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II|
|Principal investigator||Runlin Gao, M.D., Prof.|
|Description||This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.|
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