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

MicroPort

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Device: FirehawkTM 2.25mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688868

Firehawk_SS

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

new specifications (Diameter 2.25mm)of Firehawk stent

Experimental group

Description:

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

Treatment:

Device: FirehawkTM 2.25mm