Coronary Heart Disease
Conditions
Brief summary
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.
Interventions
DEVICEFirehawkTM 2.25mm
Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems
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 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent Late Loss | 9 month after stent implantation | the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Lesion Failure | 12 months | including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization |
| Number of Participants With MACE | 12 months | a composite endpoint of all cause death, any myocardial infarction and any revascularization |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease
FirehawkTM 2.25mm: Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | New Specifications (Diameter 2.25mm)of Firehawk Stent |
|---|---|
| Age, Continuous | 60.22 years STANDARD_DEVIATION 9.82 |
| Region of Enrollment China | 38 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 38 |
| other Total, other adverse events | 32 / 38 |
| serious Total, serious adverse events | 28 / 38 |
Outcome results
Primary
In-stent Late Loss
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.
Time frame: 9 month after stent implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | In-stent Late Loss | 0.29 mm | Standard Deviation 0.57 |
Secondary
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 4 years
Population: One missed participant in 3 years follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With MACE | 11 Participants |
Secondary
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With MACE | 6 Participants |
Secondary
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With MACE | 10 Participants |
Secondary
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Time frame: 3 years
Population: One missed participant in 3 years follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With MACE | 10 Participants |
Secondary
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With Target Lesion Failure | 3 Participants |
Secondary
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With Target Lesion Failure | 4 Participants |
Secondary
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 3 years
Population: One missed participant in 3 years follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With Target Lesion Failure | 4 Participants |
Secondary
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Time frame: 4 years
Population: Two missed participant in 4 years follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| New Specifications (Diameter 2.25mm)of Firehawk Stent | Number of Participants With Target Lesion Failure | 4 Participants |