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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
PCI will be performed via the radial artery.
Global Hospital
Hyderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India
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
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
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
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
Fluoroscopy Time Used for the Procedure
Fluoroscopy time used for the procedure (minutes).
Time frame: At the end of TRI
Contrast Dye Volume Used for the Procedure
Contrast dye volume used for the procedure (mL).
Time frame: At the end of TRI
Time Used for the Procedure
Time used for the procedure (minutes).
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Tosei General Hospital
Seto, Aichi-ken, Japan
Chibaken Saiseikai Narashino Hospital
Narashino, Chiba, Japan
Shin-Koga Hospital
Kurume, Fukuoka, Japan
Kin-ikyo Central Hospital
Sapporo, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Sakurakai Takahashi Hospital
Kobe, Hyōgo, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan
...and 9 more locations
Time frame: At the end of TRI
Time Used for Hemostasis
Time Used for Hemostasis (minutes).
Time frame: within 2 days afterTRI