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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Using FIREHAWK DES treating CAD
firehawk biodegradable polymer rapamycin-eluting stent

Primary Outcomes

Device related cardiovascular composite endpoint
time frame: 12 months

Secondary Outcomes

Stent implantation success rate
time frame: 5 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by MicroPort Medical (Shanghai) Co. Ltd..