Clinical trial NCT01412164: Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: DES
CAD
FIREHAWK
MicroPort
PCI
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 diameter 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:

* Acute 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, rapamycin and metal
* Life expectation \<12 months
* History of not achieving study finish
* No compliances to the protocol
* Heart implantation subjects

Primary outcomes:
measure: TLF (Target Lesion Failure) Rate
timeFrame: 12 months after index procedure
Secondary outcomes:
measure: Stent Implantation Success Rate (SIS Rate)
timeFrame: immediately after the procedure
measure: Patient-related Cardiovascular Clinical Composite Endpoints
timeFrame: 1 years after index PCI
measure: Patient-related Cardiovascular Clinical Composite Endpoints
timeFrame: 3 years after index PCI
measure: Patient-related Cardiovascular Clinical Composite Endpoints
timeFrame: 5 years after index PCI
measure: TLF (Target Lesion Failure)
timeFrame: 1 years after index PCI
measure: TLF (Target Lesion Failure)
timeFrame: 3 years after index PCI
measure: TLF (Target Lesion Failure)
timeFrame: 5 years after index PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
affiliation: Fu Wai Hospital, Beijing, China
name: Runlin Gao, M.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.