Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Detailed Description
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The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.

Official Title
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A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Firehawk
* Device: Xience V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75, male or women who are not pregnant Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases Target lesion is primary, single artery and single lesion of coronary artery Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm Lesion diameter stenosis ≥70% Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm，diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent Exclusion Criteria: Acute heart attack within one week Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion Calcified lesion failed in pre-dilation and twisted lesion In-stent restenosis Stent implanted within one year Severe heart failure (NYHA above III) or left ventricle EF <40% Renal function damage, blood creatinine >2.0mg/dl Bleeding risk; allergic to drugs and agents used in procedure/treatment Life expectation < 12 months No compliances to the protocol Heart implantation cases Pre-specified OCT inclusion/exclusion criteria: Patients underwent 9-month angio F/U No binary restenosis at 9-month LLL between -0.01 0.2mm No mix-implanted stent No more than one bail-out stent No TLR occurred at 3 years after PCI The target vessel able to deliver the OCT catheter

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xience V<br>Implantation of Xience V drug eluting stent | Device: Xience V<br>* Implantation of Xience V drug eluting stent<br>|
| Experimental: Firehawk<br>Implantation of Firehawk drug eluting stent | Device: Firehawk<br>* Implantation of Firehawk drug eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9 Months In-stent Late Lumen Loss | To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9 Months In-stent Diameter Stenosis | the in-stent diameter stenosis 9 months post-procedure | 9 months | 
| Target Lesion Failure(TLF) Rate | Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR). | 1 years after index PCI | 
| TLF(Target Lumen Failure) Rate | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 3 years after index PCI (Percutaneous Coronary Intervention) | 
| TLF(Target Lumen Failure) | percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death. | 5 years after index PCI | 
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) |  | 1 years after index PCI | 
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) |  | 3 years after index PCI | 
| Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable) |  | 5 years after index PCI |