Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

Coronary Artery Disease Clinical Trial

Official title:

A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease: TARGET II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412164
• Other study ID #: TARGET II
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.

Description:

This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: January 2017
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75, male or unpregnant women

• Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI

• Native coronary artery target lesion

• Target lesion length <=60mm, target lesion vessel diameter 2.25mm-4.0mm

• Target lesion diameter stenosis>=70%

• For each target lesion, Firehawk stent implantation only

• Understand the study purpose, willing to participate and sign the letter of consent

• Acceptance of clinical follow-up

Exclusion Criteria:

• Acute MI within 72 hours

• Unprotected LM and intervention-required three-vessel lesions

• Calcified lesion failed in pre-dilation and twisted lesion

• Bridge vessel lesion

• Any stent implanted within one year

• Severe heart failure (HYHA>=III) or LVEF<40%

• Renal deficiency, blood creatinine > 2.0mg/dl

• Bleeding tendency

• Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal

• Life expectation <12 months

• History of not achieving study finish

• No compliances to the protocol

• Heart implantation subjects

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD

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	TLF (Target Lesion Failure) Rate	Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR	12 months after index procedure
Secondary	Stent Implantation Success Rate (SIS Rate)	Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III	immediately after the procedure
Secondary	Patient-related Cardiovascular Clinical Composite Endpoints	Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.	1 years after index PCI
Secondary	Patient-related Cardiovascular Clinical Composite Endpoints	Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.	3 years after index PCI
Secondary	Patient-related Cardiovascular Clinical Composite Endpoints	Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.	5 years after index PCI
Secondary	TLF (Target Lesion Failure)	Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR	1 years after index PCI
Secondary	TLF (Target Lesion Failure)	Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR	3 years after index PCI
Secondary	TLF (Target Lesion Failure)	Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure	5 years after index PCI