Trial Outcomes & Findings for Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 ) (NCT NCT02688868)
NCT ID: NCT02688868
Last Updated: 2023-10-23
Results Overview
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
9 month after stent implantation
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )
Baseline characteristics by cohort
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 Participants
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
|
|---|---|
|
Age, Continuous
|
60.22 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 month after stent implantationthe difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=34 Participants
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
|
|---|---|
|
In-stent Late Loss
|
0.29 mm
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: 12 monthsincluding cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsincluding cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One missed participant in 3 years follow up
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=37 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure
|
4 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Two missed participant in 4 years follow up
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=36 Participants
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
|
|---|---|
|
Number of Participants With Target Lesion Failure
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsa composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 Participants
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
|
|---|---|
|
Number of Participants With MACE
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsa composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 Participants
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
|
|---|---|
|
Number of Participants With MACE
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One missed participant in 3 years follow up
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=37 Participants
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
|
|---|---|
|
Number of Participants With MACE
|
10 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: One missed participant in 3 years follow up
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=37 Participants
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
|
|---|---|
|
Number of Participants With MACE
|
11 Participants
|
Adverse Events
New Specifications (Diameter 2.25mm)of Firehawk Stent
Serious events: 28 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 participants at risk
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
|
|---|---|
|
Cardiac disorders
target lesion revascularization
|
7.9%
3/38 • Number of events 3 • 4 years
|
|
Cardiac disorders
in-stent restenosis
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
angina
|
5.3%
2/38 • Number of events 2 • 4 years
|
|
Vascular disorders
hypotension
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
General disorders
rehospitalization
|
26.3%
10/38 • Number of events 10 • 4 years
|
|
Cardiac disorders
non target lesion revascularization
|
15.8%
6/38 • Number of events 6 • 4 years
|
|
Reproductive system and breast disorders
Epididymitis
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
Cerebral hemorrhage
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Vascular disorders
renal artery implantation
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
myocardial infarction
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
Death of cerebral infarction
|
2.6%
1/38 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
New Specifications (Diameter 2.25mm)of Firehawk Stent
n=38 participants at risk
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
|
|---|---|
|
Cardiac disorders
elevated myocardial enzyme
|
13.2%
5/38 • Number of events 5 • 4 years
|
|
Cardiac disorders
No-reflow phenomenon
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
intermediate lesion
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
Bleeding
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Infections and infestations
Fever
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
General disorders
Repeat chest & back pain
|
7.9%
3/38 • Number of events 3 • 4 years
|
|
Cardiac disorders
atrial fibrillation
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
General disorders
abnormal liver function
|
5.3%
2/38 • Number of events 2 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spondylopathy
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Neck pain
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
soft tissue disease
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Vascular disorders
perioperation hypotension
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
perioperation slow heart beat
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Sleeping disorder
|
5.3%
2/38 • Number of events 2 • 4 years
|
|
General disorders
Weight loss
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Gastroesophageal disorder
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Vascular disorders
Varicosity
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
Heart dysfunction
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
Myocardial injury
|
26.3%
10/38 • Number of events 10 • 4 years
|
|
Cardiac disorders
rapid heart beat
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Cardiac disorders
Chest distress
|
13.2%
5/38 • Number of events 5 • 4 years
|
|
Cardiac disorders
Chest pain
|
15.8%
6/38 • Number of events 6 • 4 years
|
|
Metabolism and nutrition disorders
unsatifactory blood glucose control
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
lumbago
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Ear and labyrinth disorders
Deaf
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
syncope
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
Numbness
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
peripheral neuropathy
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Nervous system disorders
disc herniation
|
2.6%
1/38 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Fasciitis
|
2.6%
1/38 • Number of events 1 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place