The First-In-Man Pilot Study of Firehawk
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapamycin target-eluting Coronary Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Sirolimus eluting stents, percutaneous coronary intervention, First in man
Eligibility Criteria
Inclusion Criteria:
- 18-75 years of age, males or non-pregnant females;
- With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
- Total number of target lesion is 1;
- Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
- Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
- Each target lesion may be covered by a single stent;
- Patients with indications for coronary artery bypass graft surgery;
- To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Exclusion Criteria:
- Within 1 month of any acute myocardial infarction;
- 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;
- Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
- In-stent Restenosis lesions;
- Intracoronary implantation of any branding stents within 1 year;
- Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
- Preoperative renal function serum creatinine >2.0mg/DL;
- 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;
- Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
- The patient's life expectancy is less than 12 months;
- Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
- Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
- Heart transplantation patients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02688829
First Posted
February 18, 2016
Last Updated
September 26, 2019
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02688829
Brief Title
The First-In-Man Pilot Study of Firehawk
Official Title
The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Sirolimus eluting stents, percutaneous coronary intervention, First in man
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
Intervention Type
Device
Intervention Name(s)
Rapamycin target-eluting Coronary Stent System
Other Intervention Name(s)
Firehawk
Intervention Description
Implantation of the rapamycin-eluting coronary stent system
Primary Outcome Measure Information:
Title
Count of Participants With MACE (Major Acute Cardiovascular Events)
Description
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.
Time Frame
1 month after stent implantation
Secondary Outcome Measure Information:
Title
In-stent Late Lumen Loss
Description
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.
Time Frame
4 months after stent implantation
Title
Count of Participants With MACE (Major Acute Cardiovascular Events)
Description
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.
Time Frame
4 month after stent implantation
Title
Percentage of In-stent Diameter Stenosis
Description
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.
Time Frame
4 months after stent implantation
Title
In-stent Late Lumen Loss
Description
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.
Time Frame
13 month after stent implantation
Title
Count of Participants With MACE (Major Acute Cardiovascular Events)
Description
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.
Time Frame
13 month after stent implantation
Title
Percentage of In-stent Diameter Stenosis
Description
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.
Time Frame
13 month after stent implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years of age, males or non-pregnant females;
With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
Total number of target lesion is 1;
Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
Each target lesion may be covered by a single stent;
Patients with indications for coronary artery bypass graft surgery;
To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
Exclusion Criteria:
Within 1 month of any acute myocardial infarction;
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;
Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
In-stent Restenosis lesions;
Intracoronary implantation of any branding stents within 1 year;
Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
Preoperative renal function serum creatinine >2.0mg/DL;
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;
Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
The patient's life expectancy is less than 12 months;
Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
Heart transplantation patients.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The First-In-Man Pilot Study of Firehawk
We'll reach out to this number within 24 hrs