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

MicroPort

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: FIREHAWK biodegradable polymer rapamycin-eluting stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01412164

TARGET II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 730 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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730 participants in 1 patient group

Firehawk

Experimental group

Description:

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Treatment:

Device: FIREHAWK biodegradable polymer rapamycin-eluting stent