Trial Outcomes & Findings for The First-In-Man Pilot Study of Firehawk (NCT NCT02688829)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

1 month after stent implantation

Results posted on

2019-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The First-In-Man Pilot Study of Firehawk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=21 Participants 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
Age, Continuous	56.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment China	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group n=21 Participants 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
Count of Participants With MACE (Major Acute Cardiovascular Events)	0 Participants

SECONDARY outcome

Timeframe: 4 months after stent implantation

Population: Angiographic follow-up at 4 months was obtained in 19 patients.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants 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
In-stent Late Lumen Loss	0.13 mm Standard Deviation 0.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group n=21 Participants 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
Count of Participants With MACE (Major Acute Cardiovascular Events)	0 Participants

SECONDARY outcome

Timeframe: 4 months after stent implantation

Population: Angiographic follow-up at 4 months was obtained in 19 patients.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants 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
Percentage of In-stent Diameter Stenosis	13.4 percentage of lumen diameter Standard Deviation 6.5

SECONDARY outcome

Timeframe: 13 month after stent implantation

Population: Angiographic follow-up at 13months was obtained in 19 patients.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants 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
In-stent Late Lumen Loss	0.16 mm Standard Deviation 0.07

SECONDARY outcome

Timeframe: 13 month after stent implantation

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=21 Participants 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
Count of Participants With MACE (Major Acute Cardiovascular Events)	0 Participants

SECONDARY outcome

Timeframe: 13 month after stent implantation

Population: Angiographic follow-up at 4 months was obtained in 19 patients.

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=19 Participants 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
Percentage of In-stent Diameter Stenosis	12.9 percentage of lumen diameter Standard Deviation 4.7

Adverse Events

Treatment Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=21 participants at risk 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
Cardiac disorders TVR	4.8% 1/21 • Number of events 1
Nervous system disorders Hemorrhagic stroke	4.8% 1/21 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Zhang Haotian

Microport Medical, Shanghai, China

Phone: 8621-38954600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place