Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease

Coronary Heart Disease Clinical Trial

— Firehawk_38  

Official title:

The Safety and Effectiveness Evaluation of New Specifications (38mm) 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: NCT02688842
• Other study ID #: Firehawk_LS
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2021

Study information

• Verified date: May 2021
• 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 (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2021
• Est. primary completion date: January 2016
• 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 2.75mm or 4.0mm (Visual method);

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

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

7. With indications for coronary artery bypass surgery;

8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging 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;

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:
• Rapamycin target-eluting coronary stent systems (38mm)

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 Lumen Loss		9 month after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	30 days after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	6months after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	12 months after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	2 years after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	3 years after stent implantation
Secondary	Participants With Target Lesion Failure	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)	4 years after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	30 days after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	6 months after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	12 months after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	2 years after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	3 years after stent implantation
Secondary	Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	4 years after stent implantation