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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

FIREHAWK biodegradable polymer rapamycin-eluting stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring DES, CAD, FIREHAWK, MicroPort, PCI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fuwai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Firehawk

Arm Description

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

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

TLF (Target Lesion Failure)

Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

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

Full Information

NCT ID

NCT01412164

First Posted

August 5, 2011

Last Updated

August 12, 2019

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01412164

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

DES, CAD, FIREHAWK, MicroPort, PCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

730 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Firehawk

Arm Type

Experimental

Arm Description

Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD

Intervention Type

Device

Intervention Name(s)

FIREHAWK biodegradable polymer rapamycin-eluting stent

Intervention Description

DES PCI for CAD

Primary Outcome Measure Information:

Title

TLF (Target Lesion Failure) Rate

Description

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 Outcome Measure Information:

Title

Stent Implantation Success Rate (SIS Rate)

Description

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

Title

Patient-related Cardiovascular Clinical Composite Endpoints

Description

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

Title

Patient-related Cardiovascular Clinical Composite Endpoints

Description

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

Title

Patient-related Cardiovascular Clinical Composite Endpoints

Description

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

Title

TLF (Target Lesion Failure)

Description

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

Title

TLF (Target Lesion Failure)

Description

Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

Time Frame

3 years after index PCI

Title

TLF (Target Lesion Failure)

Description

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

Time Frame

5 years after index PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao, M.D., Prof.

Organizational Affiliation

Fu Wai Hospital, Beijing, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25678281

Citation

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.

Results Reference

derived

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

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