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

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.

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