Clinical trial NCT00815997: Novel Angioplasty Using Coronary Accessor
Official title: Novel Angioplasty USIng Coronary Accessor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patency of the Radial Artery
Keywords: radial artery
transradial intervention
stent
Lead sponsor: NAUSICA Investigators
Sponsor class: NETWORK
Collaborators: name: NPO International TRI Network
First posted: 2008-12-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

* Exclusion criteria included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.

Primary outcomes:
measure: Number of Patients With Radial Artery Occlusion
timeFrame: within 2 days after TRI
Secondary outcomes:
measure: Number of Patients With Successful PCI
timeFrame: within 2 days after TRI
measure: Number of Patients With Measure Adverse Cardiac Event (MACE)
timeFrame: within 2 days after TRI
measure: Number of Patients With Access-site Complications
timeFrame: within 2 days after TRI
measure: Fluoroscopy Time Used for the Procedure
timeFrame: At the end of TRI
measure: Contrast Dye Volume Used for the Procedure
timeFrame: At the end of TRI
measure: Time Used for the Procedure
timeFrame: At the end of TRI
measure: Time Used for Hemostasis
timeFrame: within 2 days afterTRI
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Global Hospital
state: AP
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
state: AP
city: Seto
country: Japan
facility: Tosei General Hospital
state: Aichi
city: Narashino
country: Japan
facility: Chibaken Saiseikai Narashino Hospital
state: Chiba
city: Kurume
country: Japan
facility: Shin-Koga Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Kin-ikyo Central Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Sakurakai Takahashi Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Atsugi
country: Japan
facility: Shonan Atsugi Hospital
state: Kanagawa
city: Isehara
country: Japan
facility: Tokai University
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Yatsushiro
country: Japan
facility: Kumamoto Rosai Hospital
state: Kumamoto
city: Shimotsuke
country: Japan
facility: Jichi Medical University
state: Tochigi
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Heart Clinic
city: Kyoto
country: Japan
facility: Kyoto Kujo Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Pai-Tou
Study officials:
affiliation: Vice Preseident, Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.