Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment des implantation
Phase phase 3
Sponsor MicroPort Medical (Shanghai) Co. Ltd.
Start date September 2010
End date September 2012
Trial size 510 participants
Trial identifier NCT01196819, Target I

Summary

The purpose of this randomized study is to evaluate new generation of MicroPort's DES of its safety, efficacy and delivery system in treating CAD.

The end point is to observe in-stent late lumen loss after 9 months of the stent implantation. The second end point is to study in-stent percent diameter stenosis.

This study is based on non-inferior assumption (vs. Xience V DES), requiring both end points reach statistical significance.

Prespecified OCT follow-up is planned at 3-Year after index PCI at 3 chosen hospitals.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Use Xience V DES as control group
des implantation
Implant DES for CAD cases
(Experimental)
Use MicroPort's new generation of Firehawk drug eluting stent
des implantation
Implant DES for CAD cases

Primary Outcomes

Measure
9 months in-stent late lumen loss
time frame: 9 months

Secondary Outcomes

Measure
9 months in-stent percent diameter stenosis
time frame: 9 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Prospective Multicenter Randomized Trial Assessing the Safety and Effectiveness of FIREHAWK BiodeGradable Polymer TArget Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease: TARGET I Trial
Principal investigator Runlin Gao, Pro & MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by MicroPort Medical (Shanghai) Co. Ltd..