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

MicroPort

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Firehawk; Device: Xience V

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196819

Target I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 458 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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458 participants in 2 patient groups

Xience V

Active Comparator group

Description:

Implantation of Xience V drug eluting stent

Treatment:

Device: Xience V

Firehawk

Experimental group

Description:

Implantation of Firehawk drug eluting stent

Treatment:

Device: Firehawk