Status:
COMPLETED
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
Lead Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT01412164
Start Date
August 1 2011
End Date
January 1 2017
Last Update
August 26 2019
Active Locations (1)
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1
Fuwai Hospital
Beijing, China