Novel Angioplasty Using Coronary Accessor (NAUSICA)
| Tracking Information | |||||
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| First Received Date ICMJE | December 29, 2008 | ||||
| Last Updated Date | October 31, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pulsation of the radial artery [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00815997 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
success of TRI [ Time Frame: within 2 days after TRI ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Novel Angioplasty Using Coronary Accessor | ||||
| Official Title ICMJE | Novel Angioplasty USIng Coronary Accessor | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Patency of the Radial Artery | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 177 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India, Japan, Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00815997 | ||||
| Other Study ID Numbers ICMJE | 2008-28 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Shigeru Saito, NAUSICA Investigators | ||||
| Study Sponsor ICMJE | NAUSICA Investigators | ||||
| Collaborators ICMJE | NPO International TRI Network | ||||
| Investigators ICMJE |
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| Information Provided By | NAUSICA Investigators | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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