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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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:

Arm && Interventions

Group	Intervention	Description
Xience V	Xience V	Implantation of Xience V drug eluting stent
Firehawk	Firehawk	Implantation of Firehawk drug eluting stent

Primary Outcome Measures

Name	Time	Method
9 Months In-stent Late Lumen Loss	9 months	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

Secondary Outcome Measures

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