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| Name | Class |
|---|---|
| NPO International TRI Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-Fr TRI (transradial coronary intervention) | Sham Comparator | TRI will be performed using a 6-Fr guiding catheter. |
|
| 4-Fr TRI | Active Comparator | TRI will be performed using a 4-Fr guiding catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI (percutaneous coronary intervention) | Procedure | PCI will be performed via the radial artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 2 days after TRI |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 2 days after TRI |
| Number of Patients With Measure Adverse Cardiac Event (MACE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Vice Preseident, Shonan Kamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Hospital | Hyderabad | Andhra Pradesh | India | |||
| Krishna Institute of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24786357 | Derived | Takeshita S, Asano H, Hata T, Hibi K, Ikari Y, Kan Y, Katsuki T, Kawasaki T, Masutani M, Matsumura T, Premchand RK, Rao SP, Suzuki T, Takahashi A, Takeda R, Tanaka S, Yamazaki S, Yin WH, Yoshimachi F, Saito S; NAUSICA Trial Investigators. Comparison of frequency of radial artery occlusion after 4Fr versus 6Fr transradial coronary intervention (from the Novel Angioplasty USIng Coronary Accessor Trial). Am J Cardiol. 2014 Jun 15;113(12):1986-9. doi: 10.1016/j.amjcard.2014.03.040. Epub 2014 Apr 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 Fr TRI | TRI will be performed using a 6-Fr guiding catheter. |
| FG001 | 4-Fr TRI | TRI will be performed using a 4-Fr guiding catheter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The trial was powered to show the noninferiority of 4-Fr compared with 6-Fr in achieving the primary endpoint of radial artery patency, with a 2-sided alpha level of 0.05. Assuming a radial artery occlusion rate of 1% in the 4-Fr and 6% in the 6-Fr, with a noninferiority margin, δ, of 5%.
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 Fr TRI | TRI will be performed using a 6-Fr guiding catheter. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | within 2 days after TRI |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 6 Fr TRI | TRI will be performed using a 6-Fr guiding catheter. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sigeru Saito, MD, Principal Investigator | NPO International TRI Network | +81-467-461717 | 10490 | saito@shonankamakura.or.jp |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization |
| within 2 days after TRI |
| 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. | within 2 days after TRI |
| Fluoroscopy Time Used for the Procedure | Fluoroscopy time used for the procedure (minutes). | At the end of TRI |
| Contrast Dye Volume Used for the Procedure | Contrast dye volume used for the procedure (mL). | At the end of TRI |
| Time Used for the Procedure | Time used for the procedure (minutes). | At the end of TRI |
| Time Used for Hemostasis | Time Used for Hemostasis (minutes). | within 2 days afterTRI |
| Secunderabad |
| Andhra Pradesh |
| 500003 |
| India |
| Tosei General Hospital | Seto | Aichi-ken | 489-8652 | Japan |
| Chibaken Saiseikai Narashino Hospital | Narashino | Chiba | 275-0006 | Japan |
| Shin-Koga Hospital | Kurume | Fukuoka | 830-8577 | Japan |
| Kin-ikyo Central Hospital | Sapporo | Hokkaido | 007-8505 | Japan |
| Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | 065-0033 | Japan |
| Sakurakai Takahashi Hospital | Kobe | Hyōgo | 654-0026 | Japan |
| Hyogo College of Medicine | Nishinomiya | Hyōgo | 665-8501 | Japan |
| Shonan Atsugi Hospital | Atsugi | Kanagawa | 243-8551 | Japan |
| Tokai University | Isehara | Kanagawa | 259-1193 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Yokohama City University Medical Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Kumamoto Rosai Hospital | Yatsushiro | Kumamoto | 866-8533 | Japan |
| Jichi Medical University | Shimotsuke | Tochigi | 329-0498 | Japan |
| Aomori Prefectural Central Hospital | Aomori | 030-8553 | Japan |
| Fukuoka Heart Clinic | Fukuoka | 813-0036 | Japan |
| Kyoto Kujo Hospital | Kyoto | 601-8453 | Japan |
| Cheng Hsin General Hospital | Taipei | Pai-Tou | 112 | Taiwan |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| 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. | Posted | Number | participants | within 2 days after TRI |
|
|
|
| Secondary | Number of Patients With Measure Adverse Cardiac Event (MACE) | Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization | Posted | Number | participants | within 2 days after TRI |
|
|
|
| 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. | Posted | Count of Participants | Participants | within 2 days after TRI |
|
|
|
| Secondary | Fluoroscopy Time Used for the Procedure | Fluoroscopy time used for the procedure (minutes). | Posted | Mean | Standard Deviation | minutes | At the end of TRI |
|
|
|
| Secondary | Contrast Dye Volume Used for the Procedure | Contrast dye volume used for the procedure (mL). | Posted | Mean | Standard Deviation | mL | At the end of TRI |
|
|
|
| Secondary | Time Used for the Procedure | Time used for the procedure (minutes). | Posted | Mean | Standard Deviation | minutes | At the end of TRI |
|
|
|
| Secondary | Time Used for Hemostasis | Time Used for Hemostasis (minutes). | Posted | Mean | Standard Error | minutes | within 2 days afterTRI |
|
|
|
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 4-Fr TRI | TRI will be performed using a 4-Fr guiding catheter. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D019060 | Minimally Invasive Surgical Procedures |