Coronary Artery Disease
Conditions
Keywords
DES, CAD, FIREHAWK, MicroPort, PCI
Brief summary
The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
Detailed description
This is a prospective open-labeled, multi-center, single-arm observational registry study. Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month. Also, the study will follow up those subjects up to 5 years as the secondary endpoints.
Interventions
DEVICEFIREHAWK biodegradable polymer rapamycin-eluting stent
DES PCI for CAD
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
* Age 18-75, male or unpregnant women * Evidence of non-symptomatic ischemia, stable or non-stable angina or past MI * Native coronary artery target lesion * Target lesion length \<=60mm, target lesion vessel diameter 2.25mm-4.0mm * Target lesion diameter stenosis\>=70% * For each target lesion, Firehawk stent implantation only * Understand the study purpose, willing to participate and sign the letter of consent * Acceptance of clinical follow-up
Exclusion criteria
* Acute MI within 72 hours * Unprotected LM and intervention-required three-vessel lesions * Calcified lesion failed in pre-dilation and twisted lesion * Bridge vessel lesion * Any stent implanted within one year * Severe heart failure (HYHA\>=III) or LVEF\<40% * Renal deficiency, blood creatinine \> 2.0mg/dl * Bleeding tendency * Allergic to aspirin, clopidogrel, ticlopidine, dye, rapamycin and metal * Life expectation \<12 months * History of not achieving study finish * No compliances to the protocol * Heart implantation subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLF (Target Lesion Failure) Rate | 12 months after index procedure | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Implantation Success Rate (SIS Rate) | immediately after the procedure | Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III |
| Patient-related Cardiovascular Clinical Composite Endpoints | 1 years after index PCI | Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction. |
| TLF (Target Lesion Failure) | 1 years after index PCI | Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Firehawk Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD
FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD | 730 |
| Total | 730 |
Baseline characteristics
| Characteristic | Firehawk |
|---|---|
| Age, Continuous | 58.71 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment China | 730 participants |
| Sex: Female, Male Female | 213 Participants |
| Sex: Female, Male Male | 517 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 30 / 683 |
| other Total, other adverse events | 0 / 730 |
| serious Total, serious adverse events | 112 / 683 |
Outcome results
Primary
TLF (Target Lesion Failure) Rate
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
Time frame: 12 months after index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Firehawk | TLF (Target Lesion Failure) Rate | 4.4 percentage of participants with TLF |
Secondary
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Time frame: 1 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Firehawk | Patient-related Cardiovascular Clinical Composite Endpoints | 46 Participants |
Secondary
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Time frame: 3 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Firehawk | Patient-related Cardiovascular Clinical Composite Endpoints | 77 Participants |
Secondary
Patient-related Cardiovascular Clinical Composite Endpoints
Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.
Time frame: 5 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Firehawk | Patient-related Cardiovascular Clinical Composite Endpoints | 112 Participants |
Secondary
Stent Implantation Success Rate (SIS Rate)
Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III
Time frame: immediately after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Firehawk | Stent Implantation Success Rate (SIS Rate) | 96.8 percentage of participants with SIS |
Secondary
TLF (Target Lesion Failure)
Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
Time frame: 5 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Firehawk | TLF (Target Lesion Failure) | 59 Participants |
Secondary
TLF (Target Lesion Failure)
Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
Time frame: 1 years after index PCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Firehawk | TLF (Target Lesion Failure) | 4.38 percentage of participants with TLF |
Secondary
TLF (Target Lesion Failure)
Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR
Time frame: 3 years after index PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Firehawk | TLF (Target Lesion Failure) | 46 Participants |