Back to results

Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

FirehawkTM 2.25mm

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-80 years of age, males or non-pregnant women;
Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
Primary target lesion, in situ coronary artery disease;
Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);
The target lesion diameter stenosis ≥ 70% (Visual method);
Each target lesion implantation the same stent (Firehawk stent);
With indications for coronary artery bypass surgery;
To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion Criteria:

Within 72h of any acute myocardial infarction;
Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
Artery and/or vein bypass graft lesions;
Intracoronary implantation of any branding stents within 1 year;
Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (ultrasound or left ventricular angiography);
Preoperative renal function serum creatinine >2.0mg/DL;
Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
The patient's life expectancy is less than 12 months;
Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
Heart transplantation patients.

Sites / Locations

Fu Wai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

new specifications (Diameter 2.25mm)of Firehawk stent

Arm Description

Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease

Outcomes

Primary Outcome Measures

In-stent Late Loss

the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.

Secondary Outcome Measures

Number of Participants With Target Lesion Failure

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Number of Participants With Target Lesion Failure

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Number of Participants With Target Lesion Failure

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Number of Participants With Target Lesion Failure

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Number of Participants With MACE

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Number of Participants With MACE

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Number of Participants With MACE

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Number of Participants With MACE

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Full Information

NCT ID

NCT02688868

First Posted

February 18, 2016

Last Updated

October 17, 2023

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02688868

Brief Title

Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

Official Title

The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 2014 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2020 (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 purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

6. Conditions and Keywords

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

Coronary Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

new specifications (Diameter 2.25mm)of Firehawk stent

Arm Type

Experimental

Arm Description

Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease

Intervention Type

Device

Intervention Name(s)

FirehawkTM 2.25mm

Intervention Description

Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems

Primary Outcome Measure Information:

Title

In-stent Late Loss

Description

the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.

Time Frame

9 month after stent implantation

Secondary Outcome Measure Information:

Title

Number of Participants With Target Lesion Failure

Description

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Time Frame

12 months

Title

Number of Participants With Target Lesion Failure

Description

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Time Frame

2 years

Title

Number of Participants With Target Lesion Failure

Description

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Time Frame

3 years

Title

Number of Participants With Target Lesion Failure

Description

including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization

Time Frame

4 years

Title

Number of Participants With MACE

Description

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Time Frame

12 months

Title

Number of Participants With MACE

Description

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Time Frame

2 years

Title

Number of Participants With MACE

Description

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Time Frame

3 years

Title

Number of Participants With MACE

Description

a composite endpoint of all cause death, any myocardial infarction and any revascularization

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-80 years of age, males or non-pregnant women; Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina; Primary target lesion, in situ coronary artery disease; Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method); The target lesion diameter stenosis ≥ 70% (Visual method); Each target lesion implantation the same stent (Firehawk stent); With indications for coronary artery bypass surgery; To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up. Exclusion Criteria: Within 72h of any acute myocardial infarction; Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge; Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery; Artery and/or vein bypass graft lesions; Intracoronary implantation of any branding stents within 1 year; Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (ultrasound or left ventricular angiography); Preoperative renal function serum creatinine >2.0mg/DL; Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy; Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies; The patient's life expectancy is less than 12 months; Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame; Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements; Heart transplantation patients.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao, MD

Organizational Affiliation

Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fu Wai Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

We'll reach out to this number within 24 hrs