Trial Outcomes & Findings for Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD) (NCT NCT01412164)

Results Overview

Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

730 participants

Primary outcome timeframe

12 months after index procedure

Results posted on

2019-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Firehawk Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Overall Study STARTED	730
Overall Study COMPLETED	683
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Firehawk n=730 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Age, Continuous	58.71 years STANDARD_DEVIATION 8.90 • n=5 Participants
Sex: Female, Male Female	213 Participants n=5 Participants
Sex: Female, Male Male	517 Participants n=5 Participants
Region of Enrollment China	730 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Firehawk n=730 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
TLF (Target Lesion Failure) Rate	4.4 percentage of participants with TLF

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Firehawk n=730 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Stent Implantation Success Rate (SIS Rate)	96.8 percentage of participants with SIS

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Firehawk n=730 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Patient-related Cardiovascular Clinical Composite Endpoints	46 Participants

SECONDARY outcome

Timeframe: 3 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.

Outcome measures

Outcome measures
Measure	Firehawk n=712 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Patient-related Cardiovascular Clinical Composite Endpoints	77 Participants

SECONDARY outcome

Timeframe: 5 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.

Outcome measures

Outcome measures
Measure	Firehawk n=683 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Patient-related Cardiovascular Clinical Composite Endpoints	112 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Firehawk n=730 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
TLF (Target Lesion Failure)	4.38 percentage of participants with TLF

SECONDARY outcome

Timeframe: 3 years after index PCI

Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR

Outcome measures

Outcome measures
Measure	Firehawk n=712 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
TLF (Target Lesion Failure)	46 Participants

SECONDARY outcome

Timeframe: 5 years after index PCI

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

Outcome measures

Outcome measures
Measure	Firehawk n=683 Participants Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
TLF (Target Lesion Failure)	59 Participants

Adverse Events

Firehawk

Serious events: 112 serious events

Other events: 0 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Firehawk n=730 participants at risk；n=683 participants at risk Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Cardiac disorders Perioperative myocardial infarction	5.6% 38/683
Cardiac disorders Target lesion revascularization	9.8% 67/683
Psychiatric disorders Death	4.4% 30/683
Cardiac disorders Definite/probable in-stent thrombosis	0.73% 5/683

Other adverse events

Other adverse events
Measure	Firehawk n=730 participants at risk；n=683 participants at risk Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD
Cardiac disorders Arrhythmia	0.00% 0/730

Additional Information

Kefei Li

Shanghai Microport Medical (Group) Co.,Ltd.

Phone: +86-21-38954600×6700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place