Trial Outcomes & Findings for Novel Angioplasty Using Coronary Accessor (NCT NCT00815997)

Results Overview

The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

within 2 days after TRI

Results posted on

2019-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	6 Fr TRI TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI TRI will be performed using a 4-Fr guiding catheter.
Overall Study STARTED	80	80
Overall Study COMPLETED	80	80
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Angioplasty Using Coronary Accessor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter. TRI using a 4-Fr guiding catheter: TRI will be performed using a 4-Fr guiding catheter.	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	38 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 11 • n=5 Participants	68 years STANDARD_DEVIATION 11 • n=7 Participants	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	62 Participants n=7 Participants	137 Participants n=5 Participants
Region of Enrollment Taiwan	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Japan	61 participants n=5 Participants	60 participants n=7 Participants	121 participants n=5 Participants
Region of Enrollment India	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: within 2 days after TRI

The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Number of Patients With Radial Artery Occlusion	3 Participants	0 Participants

SECONDARY outcome

Timeframe: within 2 days after TRI

Procedural success was defined as a postprocedural residual stenosis of less than 20%, and a thrombolysis in myocardial infarction (TIMI) grade 3 angiographic flow without MACE during in-hospital follow-up.

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Number of Patients With Successful PCI	79 participants	79 participants

SECONDARY outcome

Timeframe: within 2 days after TRI

Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Number of Patients With Measure Adverse Cardiac Event (MACE)	0 participants	0 participants

SECONDARY outcome

Timeframe: within 2 days after TRI

Access-site-related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion.

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Number of Patients With Access-site Complications	5 Participants	0 Participants

SECONDARY outcome

Timeframe: At the end of TRI

Fluoroscopy time used for the procedure (minutes).

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Fluoroscopy Time Used for the Procedure	12 minutes Standard Deviation 11	13 minutes Standard Deviation 9

SECONDARY outcome

Timeframe: At the end of TRI

Contrast dye volume used for the procedure (mL).

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Contrast Dye Volume Used for the Procedure	101 mL Standard Deviation 68	87 mL Standard Deviation 45

SECONDARY outcome

Timeframe: At the end of TRI

Time used for the procedure (minutes).

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Time Used for the Procedure	37 minutes Standard Deviation 22	37 minutes Standard Deviation 21

SECONDARY outcome

Timeframe: within 2 days afterTRI

Time Used for Hemostasis (minutes).

Outcome measures

Outcome measures
Measure	6 Fr TRI n=80 Participants TRI will be performed using a 6-Fr guiding catheter.	4-Fr TRI n=80 Participants TRI will be performed using a 4-Fr guiding catheter.
Time Used for Hemostasis	320 minutes Standard Error 238	237 minutes Standard Error 105

Adverse Events

6 Fr TRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4-Fr TRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sigeru Saito, MD, Principal Investigator

NPO International TRI Network

Phone: +81-467-461717

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place