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

Coronary Heart Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688868
• Other study ID #: Firehawk_SS
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2020
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18-80 years of age, males or non-pregnant women;

2. Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;

3. Primary target lesion, in situ coronary artery disease;

4. Target lesion length = 60mm, target lesion diameter 2.25mm (Visual method);

5. The target lesion diameter stenosis = 70% (Visual method);

6. Each target lesion implantation the same stent (Firehawk stent);

7. With indications for coronary artery bypass surgery;

8. To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion Criteria:

1. Within 72h of any acute myocardial infarction;

2. Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;

3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;

4. Artery and/or vein bypass graft lesions;

5. Intracoronary implantation of any branding stents within 1 year;

6. Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (ultrasound or left ventricular angiography);

7. Preoperative renal function serum creatinine >2.0mg/DL;

8. 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;

9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;

10. The patient's life expectancy is less than 12 months;

11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;

12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;

13. Heart transplantation patients.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Fu Wai Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 month after stent implantation
Secondary	Number of Participants With Target Lesion Failure	including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization	12 months
Secondary	Number of Participants With Target Lesion Failure	including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization	2 years
Secondary	Number of Participants With Target Lesion Failure	including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization	3 years
Secondary	Number of Participants With Target Lesion Failure	including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization	4 years
Secondary	Number of Participants With MACE	a composite endpoint of all cause death, any myocardial infarction and any revascularization	12 months
Secondary	Number of Participants With MACE	a composite endpoint of all cause death, any myocardial infarction and any revascularization	2 years
Secondary	Number of Participants With MACE	a composite endpoint of all cause death, any myocardial infarction and any revascularization	3 years
Secondary	Number of Participants With MACE	a composite endpoint of all cause death, any myocardial infarction and any revascularization	4 years