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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent

• Registration Number: NCT01412164
• Lead Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2013-02
• Results First Submitted: 2016-02-19
• Results First Submitted QC: 2016-02-19
• Results First Posted: 2016-03-17
• Study Completion: 2017-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Firehawk	FIREHAWK biodegradable polymer rapamycin-eluting stent	Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Primary Outcome Measures

Name	Time	Method
TLF (Target Lesion Failure) Rate	12 months after index procedure	Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

Secondary Outcome Measures

Name	Time	Method
Stent Implantation Success Rate (SIS Rate)	immediately after the procedure	Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III
TLF (Target Lesion Failure)	5 years after index PCI	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
Patient-related Cardiovascular Clinical Composite Endpoints	5 years after index PCI	Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, China