Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
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ClinicalTrials.gov Identifier: NCT01412164 |
Recruitment Status
: Unknown
Verified February 2016 by Shanghai MicroPort Medical (Group) Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted
: August 9, 2011
Results First Posted
: March 17, 2016
Last Update Posted
: March 17, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: FIREHAWK biodegradable polymer rapamycin-eluting stent | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 730 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | August 2011 |
Actual Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | February 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Firehawk
Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
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Device: FIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD
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- Device Related Cardiovascular Composite Endpoint [ Time Frame: 12 months ]Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
- Stent Implantation Success Rate [ Time Frame: 5 years ]30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412164
China | |
Fuwai Hospital | |
Beijing, China |
Principal Investigator: | Runlin Gao, M.D., Prof. | Fu Wai Hospital, Beijing, China |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shanghai MicroPort Medical (Group) Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01412164 History of Changes |
Other Study ID Numbers: |
TARGET II |
First Posted: | August 9, 2011 Key Record Dates |
Results First Posted: | March 17, 2016 |
Last Update Posted: | March 17, 2016 |
Last Verified: | February 2016 |
Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
DES CAD FIREHAWK MicroPort PCI |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus |
Everolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |