Novel Angioplasty Using Coronary Accessor

NCT ID: NCT00815997

Last Updated: 2019-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patency of the Radial Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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6-Fr TRI (transradial coronary intervention)

TRI will be performed using a 6-Fr guiding catheter.

Group Type SHAM_COMPARATOR

PCI (percutaneous coronary intervention)

Intervention Type PROCEDURE

PCI will be performed via the radial artery.

4-Fr TRI

TRI will be performed using a 4-Fr guiding catheter.

Group Type ACTIVE_COMPARATOR

PCI (percutaneous coronary intervention)

Intervention Type PROCEDURE

PCI will be performed via the radial artery.

Interventions

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PCI (percutaneous coronary intervention)

PCI will be performed via the radial artery.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NPO International TRI Network

NETWORK

Sponsor Role collaborator

NAUSICA Investigators

NETWORK

Sponsor Role lead

Responsible Party

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Shigeru Saito

Vice President, Shonan Kamakura Genaral Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Vice Preseident, Shonan Kamakura General Hospital

Locations

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Global Hospital

Hyderabad, Andhra Pradesh, India

Site Status

Krishna Institute of Medical Sciences

Secunderabad, Andhra Pradesh, India

Site Status

Tosei General Hospital

Seto, Aichi-ken, Japan

Site Status

Chibaken Saiseikai Narashino Hospital

Narashino, Chiba, Japan

Site Status

Shin-Koga Hospital

Kurume, Fukuoka, Japan

Site Status

Kin-ikyo Central Hospital

Sapporo, Hokkaido, Japan

Site Status

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Site Status

Sakurakai Takahashi Hospital

Kobe, Hyōgo, Japan

Site Status

Hyogo College of Medicine

Nishinomiya, Hyōgo, Japan

Site Status

Shonan Atsugi Hospital

Atsugi, Kanagawa, Japan

Site Status

Tokai University

Isehara, Kanagawa, Japan

Site Status

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Site Status

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Site Status

Kumamoto Rosai Hospital

Yatsushiro, Kumamoto, Japan

Site Status

Jichi Medical University

Shimotsuke, Tochigi, Japan

Site Status

Aomori Prefectural Central Hospital

Aomori, , Japan

Site Status

Fukuoka Heart Clinic

Fukuoka, , Japan

Site Status

Kyoto Kujo Hospital

Kyoto, , Japan

Site Status

Cheng Hsin General Hospital

Taipei, Pai-Tou, Taiwan

Site Status

Countries

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India Japan Taiwan

References

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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.

Reference Type DERIVED
PMID: 24786357 (View on PubMed)

Other Identifiers

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2008-28

Identifier Type: -

Identifier Source: org_study_id

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