The First-In-Man Pilot Study of Firehawk

Coronary Heart Disease Clinical Trial

Official title:

The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688829
• Other study ID #: Firehawk_FIM
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: January 2015

Study information

• Verified date: September 2019
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2015
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Rapamycin target-eluting Coronary Stent System
Implantation of the rapamycin-eluting coronary stent system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Participants With MACE (Major Acute Cardiovascular Events)	Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.	1 month after stent implantation
Secondary	In-stent Late Lumen Loss	In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter.	4 months after stent implantation
Secondary	Count of Participants With MACE (Major Acute Cardiovascular Events)	Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.	4 month after stent implantation
Secondary	Percentage of In-stent Diameter Stenosis	Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%.; RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.; MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.	4 months after stent implantation
Secondary	In-stent Late Lumen Loss	In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.	13 month after stent implantation
Secondary	Count of Participants With MACE (Major Acute Cardiovascular Events)	Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.	13 month after stent implantation
Secondary	Percentage of In-stent Diameter Stenosis	Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%.; RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.; MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.	13 month after stent implantation