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

NCT ID: NCT02688868

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-12-31

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

new specifications (Diameter 2.25mm)of Firehawk stent

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

Group Type: EXPERIMENTAL

FirehawkTM 2.25mm

Intervention Type: DEVICE

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

Interventions

FirehawkTM 2.25mm

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Runlin Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Locations

Fu Wai Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Firehawk_SS

Identifier Type: -

Identifier Source: org_study_id