Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease (Firehawk_38)

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Rapamycin target-eluting coronary stent systems (38mm)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100037
      • Fu Wai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems	Device: Rapamycin target-eluting coronary stent systems (38mm); Other Names: Firehawk-38

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent Late Lumen Loss	9 month after stent implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	30 days after stent implantation
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	6 months after stent implantation
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	12 months after stent implantation
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	2 years after stent implantation
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	3 years after stent implantation
Major Adverse Cardiac Events	composite endpoint of all cause death, any myocardial infarction and any revascularization	4 years after stent implantation

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Investigators: Principal Investigator: Runlin Gao, MD, Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimated): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: Firehawk_LS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO