Novel Angioplasty Using Coronary Accessor (NAUSICA)

Novel Angioplasty USIng Coronary Accessor

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.

Study Overview

• Status: Completed
• Conditions: Patency of the Radial Artery
• Intervention / Treatment: Procedure: PCI (percutaneous coronary intervention)

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • AP
    • Hyderabad, AP, India
      • Global Hospital
    • Secunderabad, AP, India, 500003
      • Krishna Institute of Medical Sciences
• Japan
  • Aomori, Japan, 030-8553
    • Aomori Prefectural Central Hospital
  • Fukuoka, Japan, 813-0036
    • Fukuoka Heart Clinic
  • Kyoto, Japan, 601-8453
    • Kyoto Kujo Hospital
  • Aichi
    • Seto, Aichi, Japan, 489-8652
      • Tosei General Hospital
  • Chiba
    • Narashino, Chiba, Japan, 275-0006
      • Chibaken Saiseikai Narashino Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-8577
      • Shin-Koga Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 065-0033
      • Sapporo Higashi Tokushukai Hospital
    • Sapporo, Hokkaido, Japan, 007-8505
      • Kin-ikyo Central Hospital
  • Hyogo
    • Kobe, Hyogo, Japan, 654-0026
      • Sakurakai Takahashi Hospital
    • Nishinomiya, Hyogo, Japan, 665-8501
      • Hyogo College of Medicine
  • Kanagawa
    • Atsugi, Kanagawa, Japan, 243-8551
      • Shonan Atsugi Hospital
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University
    • Kamakura, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Kumamoto
    • Yatsushiro, Kumamoto, Japan, 866-8533
      • Kumamoto Rosai Hospital
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University
• Taiwan
  • Pai-Tou
    • Taipei, Pai-Tou, Taiwan, 112
      • Cheng Hsin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 6-Fr TRI (transradial coronary intervention); TRI will be performed using a 6-Fr guiding catheter.	Procedure: PCI (percutaneous coronary intervention); PCI will be performed via the radial artery.
Active Comparator: 4-Fr TRI; TRI will be performed using a 4-Fr guiding catheter.	Procedure: PCI (percutaneous coronary intervention); PCI will be performed via the radial artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: NAUSICA Investigators
• Collaborators: NPO International TRI Network
• Investigators: Principal Investigator: Shigeru Saito, MD, Vice Preseident, Shonan Kamakura General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 31, 2010
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: December 29, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (Estimate): December 31, 2008

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: stent; radial artery; transradial intervention
• Other Study ID Numbers: 2008-28