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

Shanghai MicroPort Medical (Group) Co., Ltd.730 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

730

Conditions

Coronary Artery Disease

Interventions

FIREHAWK biodegradable polymer rapamycin-eluting stentDEVICE

DES PCI for CAD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Fuwai Hospital

Beijing, China

Outcomes

Primary Outcomes

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

Time frame: 12 months after index procedure

Secondary Outcomes

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

Time frame: immediately after the procedure

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.

Time frame: 1 years after index PCI

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.

Time frame: 3 years after index PCI

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.

Time frame: 5 years after index PCI

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

Time frame: 1 years after index PCI

Data from ClinicalTrials.gov

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