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

December 29, 2008
September 2, 2013
January 2009
December 2010   (final data collection date for primary outcome measure)
pulsation of the radial artery [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00815997 on ClinicalTrials.gov Archive Site
  • 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 ]
success of TRI [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Novel Angioplasty Using Coronary Accessor
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Patency of the Radial Artery
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
  • 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.
    Intervention: Device: TRI using a 4-Fr guiding catheter
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Taiwan,   India
 
NCT00815997
2008-28
Yes
Shigeru Saito, NAUSICA Investigators
NAUSICA Investigators
NPO International TRI Network
Principal Investigator: Shigeru Saito, MD Vice Preseident, Shonan Kamakura General Hospital
NAUSICA Investigators
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP