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

A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Xience V; Device: Firehawk

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.

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xience V; Implantation of Xience V drug eluting stent	Device: Xience V; Implantation of Xience V drug eluting stent
Experimental: Firehawk; Implantation of Firehawk drug eluting stent	Device: Firehawk; Implantation of Firehawk drug eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
9 Months In-stent Late Lumen Loss	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	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Investigators: Principal Investigator: Runlin Gao, Pro & MD, Fuwai Hospital, Beijing, China

Publications and helpful links

General Publications

• Li CJ, Xu B, Guan CD, Gao RL; TARGETⅠTrial Investigators. [Long term safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of coronary de novo lesions]. Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Nov 24;45(11):940-947. doi: 10.3760/cma.j.issn.0253-3758.2017.11.009. Chinese.
• Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.
• Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL, Chen SL, Li H, Zhang RY, Fu GS, Yuan ZY, Jiang H, Huo Y, Li W, Zhang YJ, Leon MB; TARGET I Investigators. A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention. 2013 May 20;9(1):75-83. doi: 10.4244/EIJV9I1A12.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 6, 2010
• First Submitted That Met QC Criteria: September 6, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Target I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No