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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Firehawk
Xience V
Sponsored by
Shanghai MicroPort Medical (Group) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Xience V

Firehawk

Arm Description

Implantation of Xience V drug eluting stent

Implantation of Firehawk drug eluting stent

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

9 Months In-stent Diameter Stenosis
the in-stent diameter stenosis 9 months post-procedure
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).
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.
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.
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)

Full Information

First Posted
September 6, 2010
Last Updated
July 22, 2019
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01196819
Brief Title
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xience V
Arm Type
Active Comparator
Arm Description
Implantation of Xience V drug eluting stent
Arm Title
Firehawk
Arm Type
Experimental
Arm Description
Implantation of Firehawk drug eluting stent
Intervention Type
Device
Intervention Name(s)
Firehawk
Intervention Description
Implantation of Firehawk drug eluting stent
Intervention Type
Device
Intervention Name(s)
Xience V
Intervention Description
Implantation of Xience V drug eluting stent
Primary Outcome Measure Information:
Title
9 Months In-stent Late Lumen Loss
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
9 Months In-stent Diameter Stenosis
Description
the in-stent diameter stenosis 9 months post-procedure
Time Frame
9 months
Title
Target Lesion Failure(TLF) Rate
Description
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).
Time Frame
1 years after index PCI
Title
TLF(Target Lumen Failure) Rate
Description
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time Frame
3 years after index PCI (Percutaneous Coronary Intervention)
Title
TLF(Target Lumen Failure)
Description
percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.
Time Frame
5 years after index PCI
Title
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time Frame
1 years after index PCI
Title
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time Frame
3 years after index PCI
Title
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
Time Frame
5 years after index PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, Pro & MD
Organizational Affiliation
Fuwai Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29166720
Citation
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.
Results Reference
derived
PubMed Identifier
25678281
Citation
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.
Results Reference
derived
PubMed Identifier
23685298
Citation
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.
Results Reference
derived

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

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