Patency of the Radial Artery
Conditions
Keywords
radial artery, transradial intervention, stent
Brief summary
To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of radial artery occlusion after transradial coronary intervention (TRI) will be evaluated. Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr groups.
Detailed description
Prerequisites for TRI were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test. Exclusion criteria for the current study included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter. Patency of the radial artery after TRI will be evaluated by pulsation of the radial artery, and frequencies of which will be compared between those receiving 4Fr vs 6 Fr coronary interventions.
Interventions
PCI will be performed via the radial artery.
Sponsors
NPO International TRI Network
NAUSICA Investigators
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prerequisites for transradial intervention were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Radial Artery Occlusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Measure Adverse Cardiac Event (MACE) | within 2 days after TRI | Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization |
| Number of Patients With Access-site Complications | 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. |
| Fluoroscopy Time Used for the Procedure | At the end of TRI | Fluoroscopy time used for the procedure (minutes). |
| Number of Patients With Successful PCI | 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. |
| Time Used for the Procedure | At the end of TRI | Time used for the procedure (minutes). |
| Time Used for Hemostasis | within 2 days afterTRI | Time Used for Hemostasis (minutes). |
| Contrast Dye Volume Used for the Procedure | At the end of TRI | Contrast dye volume used for the procedure (mL). |
Countries
India, Japan, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 Fr TRI TRI will be performed using a 6-Fr guiding catheter. | 80 |
| 4-Fr TRI 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. | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | 6 Fr TRI | Total | 4-Fr TRI |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 90 Participants | 42 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 70 Participants | 38 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 10 | 68 years STANDARD_DEVIATION 11 |
| Region of Enrollment India | 7 participants | 17 participants | 10 participants |
| Region of Enrollment Japan | 61 participants | 121 participants | 60 participants |
| Region of Enrollment Taiwan | 12 participants | 22 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 23 Participants | 18 Participants |
| Sex: Female, Male Male | 75 Participants | 137 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Number of Patients With Radial Artery Occlusion
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.
Time frame: within 2 days after TRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 Fr TRI | Number of Patients With Radial Artery Occlusion | 3 Participants |
| 4-Fr TRI | Number of Patients With Radial Artery Occlusion | 0 Participants |
Secondary
Contrast Dye Volume Used for the Procedure
Contrast dye volume used for the procedure (mL).
Time frame: At the end of TRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Fr TRI | Contrast Dye Volume Used for the Procedure | 101 mL | Standard Deviation 68 |
| 4-Fr TRI | Contrast Dye Volume Used for the Procedure | 87 mL | Standard Deviation 45 |
Secondary
Fluoroscopy Time Used for the Procedure
Fluoroscopy time used for the procedure (minutes).
Time frame: At the end of TRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Fr TRI | Fluoroscopy Time Used for the Procedure | 12 minutes | Standard Deviation 11 |
| 4-Fr TRI | Fluoroscopy Time Used for the Procedure | 13 minutes | Standard Deviation 9 |
Secondary
Number of Patients With Access-site Complications
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.
Time frame: within 2 days after TRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 Fr TRI | Number of Patients With Access-site Complications | 5 Participants |
| 4-Fr TRI | Number of Patients With Access-site Complications | 0 Participants |
Secondary
Number of Patients With Measure Adverse Cardiac Event (MACE)
Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization
Time frame: within 2 days after TRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Fr TRI | Number of Patients With Measure Adverse Cardiac Event (MACE) | 0 participants |
| 4-Fr TRI | Number of Patients With Measure Adverse Cardiac Event (MACE) | 0 participants |
Secondary
Number of Patients With Successful PCI
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.
Time frame: within 2 days after TRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 Fr TRI | Number of Patients With Successful PCI | 79 participants |
| 4-Fr TRI | Number of Patients With Successful PCI | 79 participants |
Secondary
Time Used for Hemostasis
Time Used for Hemostasis (minutes).
Time frame: within 2 days afterTRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Fr TRI | Time Used for Hemostasis | 320 minutes | Standard Error 238 |
| 4-Fr TRI | Time Used for Hemostasis | 237 minutes | Standard Error 105 |
Secondary
Time Used for the Procedure
Time used for the procedure (minutes).
Time frame: At the end of TRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 6 Fr TRI | Time Used for the Procedure | 37 minutes | Standard Deviation 22 |
| 4-Fr TRI | Time Used for the Procedure | 37 minutes | Standard Deviation 21 |