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Novel Angioplasty Using Coronary Accessor (NAUSICA)

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ClinicalTrials.gov Identifier: NCT00815997
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : September 4, 2013
Sponsor:
Collaborator:
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators

Brief Summary:
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 or disease Intervention/treatment Phase
Patency of the Radial Artery Device: TRI using a 4-Fr guiding catheter Not Applicable

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  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Angioplasty USIng Coronary Accessor
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. pulsation of the radial artery [ Time Frame: within 2 days after TRI ]

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

  3. Puncture-site complications [ Time Frame: within 2 days after TRI ]
  4. Fluoroscopy time [ Time Frame: At the end of TRI ]
  5. Dose of radiation exposure [ Time Frame: At the end of TRI ]
  6. Contrast dye volume [ Time Frame: At the end of TRI ]
  7. Procedure time [ Time Frame: At the end of TRI ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: October 2012

Keywords provided by Shigeru Saito, NAUSICA Investigators:
radial artery
transradial intervention
stent