Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: FIREHAWK biodegradable polymer rapamycin-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firehawk<br>Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD | Device: FIREHAWK biodegradable polymer rapamycin-eluting stent<br>* DES PCI for CAD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLF (Target Lesion Failure) Rate | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 12 months after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Implantation Success Rate (SIS Rate) | Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III | immediately after the procedure | 
| Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | 1 years after index PCI | 
| Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | 3 years after index PCI | 
| Patient-related Cardiovascular Clinical Composite Endpoints | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. | 5 years after index PCI | 
| TLF (Target Lesion Failure) | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 1 years after index PCI | 
| TLF (Target Lesion Failure) | Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR | 3 years after index PCI | 
| TLF (Target Lesion Failure) | Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure | 5 years after index PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, CAD, FIREHAWK, MicroPort, PCI