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

NCT ID: NCT01412164

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-01-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Firehawk

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Group Type: EXPERIMENTAL

FIREHAWK biodegradable polymer rapamycin-eluting stent

Intervention Type: DEVICE

DES PCI for CAD

Interventions

FIREHAWK biodegradable polymer rapamycin-eluting stent

DES PCI for CAD

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Runlin Gao, M.D., Prof.

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital, Beijing, China

Locations

Fuwai Hospital

Beijing, , China

Countries

China

References

Gao Z, Zhang R, Xu B, Yang Y, Ma C, Li H, Chen S, Han Y, Yuan Z, Lansky AJ, Guan C, Leon MB, Gao R; TARGET Investigators. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:734-43. doi: 10.1002/ccd.25861. Epub 2015 Feb 19.

Reference Type: DERIVED

PMID: 25678281 (View on PubMed)

Other Identifiers

TARGET II

Identifier Type: -

Identifier Source: org_study_id