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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

458 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Xience V

Implantation of Xience V drug eluting stent

Group Type ACTIVE_COMPARATOR

Xience V

Intervention Type DEVICE

Implantation of Xience V drug eluting stent

Firehawk

Implantation of Firehawk drug eluting stent

Group Type EXPERIMENTAL

Firehawk

Intervention Type DEVICE

Implantation of Firehawk drug eluting stent

Interventions

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Firehawk

Implantation of Firehawk drug eluting stent

Intervention Type DEVICE

Xience V

Implantation of Xience V drug eluting stent

Intervention Type DEVICE

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No