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

Coronary Artery Disease Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196819
• Other study ID #: Target I
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2016

Study information

• Verified date: July 2019
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: December 2016
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Firehawk
Implantation of Firehawk drug eluting stent
• Xience V
Implantation of Xience V drug eluting stent

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 Months In-stent Diameter Stenosis	the in-stent diameter stenosis 9 months post-procedure	9 months
Secondary	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
Secondary	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)
Secondary	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
Secondary	Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)		1 years after index PCI
Secondary	Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)		3 years after index PCI
Secondary	Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)		5 years after index PCI