Novel Angioplasty Using Coronary Accessor (NAUSICA)

This study has been completed.
Sponsor:
Collaborator:
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators
ClinicalTrials.gov Identifier:
NCT00815997
First received: December 29, 2008
Last updated: September 2, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention
Patency of the Radial Artery
Device: TRI using a 4-Fr guiding catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Novel Angioplasty USIng Coronary Accessor

Resource links provided by NLM:


Further study details as provided by NAUSICA Investigators:

Primary Outcome Measures:
  • pulsation of the radial artery [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • success of PCI [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: Yes ]
    Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization

  • Puncture-site complications [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time [ Time Frame: At the end of TRI ] [ Designated as safety issue: Yes ]
  • Dose of radiation exposure [ Time Frame: At the end of TRI ] [ Designated as safety issue: Yes ]
  • Contrast dye volume [ Time Frame: At the end of TRI ] [ Designated as safety issue: Yes ]
  • Procedure time [ Time Frame: At the end of TRI ] [ Designated as safety issue: Yes ]

Enrollment: 177
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 6 Fr TRI
TRI will be performed using a 6-Fr guiding catheter.
Active Comparator: 4-Fr TRI
TRI will be performed using a 4-Fr guiding catheter.
Device: TRI using a 4-Fr guiding catheter
TRI will be performed using a 4-Fr guiding catheter.
Other Name: Heart Rail II 4-Fr guiding cathetr

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815997

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

No publications provided

Responsible Party: Shigeru Saito, Vice President, Shonan Kamakura Genaral Hospital, NAUSICA Investigators
ClinicalTrials.gov Identifier: NCT00815997     History of Changes
Other Study ID Numbers: 2008-28
Study First Received: December 29, 2008
Last Updated: September 2, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by NAUSICA Investigators:
radial artery
transradial intervention
stent

ClinicalTrials.gov processed this record on April 17, 2014