Coronary Heart Disease
Conditions
Keywords
Sirolimus eluting stents, percutaneous coronary intervention, First in man
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.
Interventions
DEVICERapamycin target-eluting Coronary Stent System
Implantation of the rapamycin-eluting coronary stent system
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With MACE (Major Acute Cardiovascular Events) | 1 month after stent implantation | 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
| Measure | Time frame | Description |
|---|---|---|
| In-stent Late Lumen Loss | 4 months after stent implantation | 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) | 4 month after stent implantation | 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 | 4 months after stent implantation | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.
Rapamycin target-eluting Coronary Stent System: Implantation of the rapamycin-eluting coronary stent system | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment China | 21 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
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.
Time frame: 1 month after stent implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Count of Participants With MACE (Major Acute Cardiovascular Events) | 0 Participants |
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.
Time frame: 13 month after stent implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Count of Participants With MACE (Major Acute Cardiovascular Events) | 0 Participants |
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.
Time frame: 4 month after stent implantation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Count of Participants With MACE (Major Acute Cardiovascular Events) | 0 Participants |
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.
Time frame: 4 months after stent implantation
Population: Angiographic follow-up at 4 months was obtained in 19 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | In-stent Late Lumen Loss | 0.13 mm | Standard Deviation 0.18 |
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.
Time frame: 13 month after stent implantation
Population: Angiographic follow-up at 13months was obtained in 19 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | In-stent Late Lumen Loss | 0.16 mm | Standard Deviation 0.07 |
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.
Time frame: 4 months after stent implantation
Population: Angiographic follow-up at 4 months was obtained in 19 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Percentage of In-stent Diameter Stenosis | 13.4 percentage of lumen diameter | Standard Deviation 6.5 |
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.
Time frame: 13 month after stent implantation
Population: Angiographic follow-up at 4 months was obtained in 19 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Percentage of In-stent Diameter Stenosis | 12.9 percentage of lumen diameter | Standard Deviation 4.7 |