The First-In-Man Pilot Study of Firehawk

NCT ID: NCT02688829

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-01-31

Brief Summary

This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.

Conditions

Coronary Heart Disease

Study Design

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

Study Groups

treatment group

Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.

Group Type: EXPERIMENTAL

Rapamycin target-eluting Coronary Stent System

Intervention Type: DEVICE

Implantation of the rapamycin-eluting coronary stent system

Interventions

Rapamycin target-eluting Coronary Stent System

Implantation of the rapamycin-eluting coronary stent system

Intervention Type: DEVICE

Other Intervention Names

Firehawk

Eligibility Criteria

Inclusion Criteria

1. 18-75 years of age, males or non-pregnant females;

2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;

3. Total number of target lesion is 1;

4. Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;

5. Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;

6. Each target lesion may be covered by a single stent;

7. Patients with indications for coronary artery bypass graft surgery;

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

Exclusion Criteria

1. Within 1 month of any acute myocardial infarction;

2. Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm 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. In-stent Restenosis lesions;

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

6. Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (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: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Firehawk_FIM

Identifier Type: -

Identifier Source: org_study_id