Trial Outcomes & Findings for Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease (NCT NCT02688842)
NCT ID: NCT02688842
Last Updated: 2023-10-23
Results Overview
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 |
Treatment Group
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 9.44 • n=38 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=38 Participants
|
|
Region of Enrollment
China
|
38 participants
n=38 Participants
|
|
Diabetes Mellitus (DM) history
With DM
|
13 Participants
n=38 Participants
|
|
Diabetes Mellitus (DM) history
Without DM
|
25 Participants
n=38 Participants
|
|
Coronary Artery Disease (CAD) history
With CAD
|
7 Participants
n=38 Participants
|
|
Coronary Artery Disease (CAD) history
Without CAD
|
31 Participants
n=38 Participants
|
|
hypertension (HTN) history
With HTN
|
27 Participants
n=38 Participants
|
|
hypertension (HTN) history
Without HTN
|
11 Participants
n=38 Participants
|
|
Cigarette usage
Never
|
17 Participants
n=38 Participants
|
|
Cigarette usage
Smoker
|
15 Participants
n=38 Participants
|
|
Cigarette usage
Quit smoking
|
1 Participants
n=38 Participants
|
|
Cigarette usage
Relapse
|
5 Participants
n=38 Participants
|
|
Myocardial Infarction (MI) history
With MI
|
13 Participants
n=38 Participants
|
|
Myocardial Infarction (MI) history
Without MI
|
25 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 9 month after stent implantationPopulation: A sum of 31 patients with 33 target lesions were analyzed by Quantitative Coronary Angiography (QCA). 7 participants did not participate in 9 month angiographic follow up.
Outcome measures
| Measure |
Treatment Group
n=33 target stent
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
In-stent Late Lumen Loss
|
0.19 mm
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 30 days after stent implantationa composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: 6months after stent implantationa composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months after stent implantationa composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 years after stent implantationa composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 years after stent implantationPopulation: One participant was lost during 3 years follow up.
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=37 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 years after stent implantationPopulation: One participant was lost during 4 years follow up.
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Outcome measures
| Measure |
Treatment Group
n=37 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Participants With Target Lesion Failure
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days after stent implantationcomposite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months after stent implantationcomposite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months after stent implantationcomposite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 years after stent implantationcomposite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=38 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 years after stent implantationPopulation: One participant was lost during 3 years follow up.
composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=37 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 years after stent implantationPopulation: One participant was lost during 4 years follow up.
composite endpoint of all cause death, any myocardial infarction and any revascularization
Outcome measures
| Measure |
Treatment Group
n=37 Participants
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Major Adverse Cardiac Events
|
7 Participants
|
Adverse Events
Treatment Group
Serious events: 15 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=38 participants at risk
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Cardiac disorders
Target Lesion Revascularization
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
Angina
|
13.2%
5/38 • Number of events 5 • 4 year follow up
|
|
General disorders
Rehospitalization
|
21.1%
8/38 • Number of events 8 • 4 year follow up
|
|
Blood and lymphatic system disorders
lymphoma
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
myocardial infarction
|
5.3%
2/38 • Number of events 2 • 4 year follow up
|
|
Cardiac disorders
non-Target Vessel Revascularization
|
10.5%
4/38 • Number of events 4 • 4 year follow up
|
|
Nervous system disorders
acute cerebral infarction
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
Diastolic dysfunction
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Gastrointestinal disorders
gastric antrum erosion
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Eye disorders
senile cataract
|
5.3%
2/38 • Number of events 2 • 4 year follow up
|
|
Cardiac disorders
coronary artery disease
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
Other adverse events
| Measure |
Treatment Group
n=38 participants at risk
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Rapamycin target-eluting coronary stent systems (38mm)
|
|---|---|
|
Cardiac disorders
elevated myocardial enzyme
|
5.3%
2/38 • Number of events 2 • 4 year follow up
|
|
Eye disorders
corneal ulcer
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
General disorders
hypokalemia
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Vascular disorders
aneurysm
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
atrial fibrillation
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Infections and infestations
Infection
|
13.2%
5/38 • Number of events 5 • 4 year follow up
|
|
Cardiac disorders
heart discomfort after movation
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Gastrointestinal disorders
Chronic gastroenteritis
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Respiratory, thoracic and mediastinal disorders
Short breath
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Renal and urinary disorders
renal cyst
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
premature ventricular contraction
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
myocardial injury
|
34.2%
13/38 • Number of events 13 • 4 year follow up
|
|
General disorders
Pain
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Nervous system disorders
vertigo
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
palpitation
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
|
Cardiac disorders
angina
|
2.6%
1/38 • Number of events 1 • 4 year follow up
|
Additional Information
Haotian Zhang
Shanghai Microport Medical (Company) Co.,Ltd.
Phone: +86-21-38954600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place