MedDataX Logo

Trial Outcomes & Findings for Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial (NCT NCT01196819)

NCT ID: NCT01196819

Last Updated: 2019-07-30

Results Overview

To observe in-stent late lumen loss after 9 months of stent implantation It means 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

458 participants

Primary outcome timeframe

9 months

Results posted on

2019-07-30

Participant Flow

Participant milestones

Participant milestones
Measure
Xience V DES as Comparative Arm
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Overall Study
STARTED
231
227
Overall Study
COMPLETED
225
227
Overall Study
NOT COMPLETED
6
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Xience V DES as Comparative Arm
n=231 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=227 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Total
n=458 Participants
Total of all reporting groups
Age, Continuous
59.97 years
STANDARD_DEVIATION 9.39 • n=5 Participants
58.95 years
STANDARD_DEVIATION 9.42 • n=7 Participants
59 years
STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male
Female
73 Participants
n=5 Participants
70 Participants
n=7 Participants
143 Participants
n=5 Participants
Sex: Female, Male
Male
158 Participants
n=5 Participants
157 Participants
n=7 Participants
315 Participants
n=5 Participants
Region of Enrollment
China
231 participants
n=5 Participants
227 participants
n=7 Participants
458 participants
n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.

To observe in-stent late lumen loss after 9 months of stent implantation It means the 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

Outcome measures
Measure
Xience V DES as Comparative Arm
n=202 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=199 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
9 Months In-stent Late Lumen Loss
0.13 mm
Standard Deviation 0.18
0.13 mm
Standard Deviation 0.24

SECONDARY outcome

Timeframe: 9 months

Population: Angiographic follow-up at nine months was completed in 87.6% (199/227) of the Firehawk DES group and 87.4% (202/231) of the Xience V DES group.

the in-stent diameter stenosis 9 months post-procedure

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=202 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=199 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
9 Months In-stent Diameter Stenosis
11.51 percentage of diameter stenosis
Standard Deviation 7.37
11.85 percentage of diameter stenosis
Standard Deviation 9.67

SECONDARY outcome

Timeframe: 1 years after index PCI

Percentage of participants with the determination of TLF. TLF is the composite of sudden cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=231 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=227 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Target Lesion Failure(TLF) Rate
2.2 percentage
2.2 percentage

SECONDARY outcome

Timeframe: 3 years after index PCI (Percutaneous Coronary Intervention)

Population: 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.

percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=228 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=222 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
TLF(Target Lumen Failure) Rate
3.51 percentage
4.05 percentage

SECONDARY outcome

Timeframe: 5 years after index PCI

Population: 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.

percentage of participants with the determination of TLF, TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=225 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=217 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
TLF(Target Lumen Failure)
6.67 percentage
5.99 percentage

SECONDARY outcome

Timeframe: 1 years after index PCI

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=231 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=227 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 3 years after index PCI

Population: 3 patients in Xience V DES group and 5 patients in Firehawk DES group failed to be contacted.

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=228 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=222 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
1 Participants
0 Participants

SECONDARY outcome

Timeframe: 5 years after index PCI

Population: 6 patients in Xience V DES group and 10 patients in Firehawk DES group failed to be contacted.

Outcome measures

Outcome measures
Measure
Xience V DES as Comparative Arm
n=225 Participants
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=217 Participants
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Number of Participants With Stent Thrombsis (ARC Defined Definite/Probable)
1 Participants
0 Participants

Adverse Events

Xience V DES as Comparative Arm

Serious events: 46 serious events
Other events: 0 other events
Deaths: 8 deaths

MicroPort Firehawk DES

Serious events: 28 serious events
Other events: 0 other events
Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure
Xience V DES as Comparative Arm
n=225 participants at risk
Use Xience V DES as control group DES implantation: Implant DES for CAD cases
MicroPort Firehawk DES
n=227 participants at risk
Use MicroPort's new generation of Firehawk drug eluting stent DES implantation: Implant DES for CAD cases
Injury, poisoning and procedural complications
death
3.6%
8/225 • 5 years
3.1%
7/227 • 5 years
Cardiac disorders
myocardial infarction
4.0%
9/225 • 5 years
2.2%
5/227 • 5 years
Surgical and medical procedures
coronary revascularization
12.4%
28/225 • 5 years
7.0%
16/227 • 5 years
Cardiac disorders
Definite/probable in-stent thrombosis
0.44%
1/225 • 5 years
0.00%
0/227 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Kefei Li

Shanghai Microport Medical (Group) Co.,Ltd.

Phone: +86-21-38954600×6700

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place