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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by NAUSICA Investigators

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014