Novel Angioplasty Using Coronary Accessor
- Conditions
- Patency of the Radial Artery
- Interventions
- Procedure: PCI (percutaneous coronary intervention)
- Registration Number
- NCT00815997
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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 included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4-Fr TRI PCI (percutaneous coronary intervention) TRI will be performed using a 4-Fr guiding catheter. 6-Fr TRI (transradial coronary intervention) PCI (percutaneous coronary intervention) TRI will be performed using a 6-Fr guiding catheter.
- Primary Outcome Measures
Name Time Method Number of Patients With Radial Artery Occlusion within 2 days after TRI The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.
- Secondary Outcome Measures
Name Time Method Number of Patients With Successful PCI within 2 days after TRI Procedural success was defined as a postprocedural residual stenosis of less than 20%, and a thrombolysis in myocardial infarction (TIMI) grade 3 angiographic flow without MACE during in-hospital follow-up.
Number of Patients With Access-site Complications within 2 days after TRI Access-site-related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion.
Number of Patients With Measure Adverse Cardiac Event (MACE) within 2 days after TRI Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization
Fluoroscopy Time Used for the Procedure At the end of TRI Fluoroscopy time used for the procedure (minutes).
Contrast Dye Volume Used for the Procedure At the end of TRI Contrast dye volume used for the procedure (mL).
Time Used for the Procedure At the end of TRI Time used for the procedure (minutes).
Time Used for Hemostasis within 2 days afterTRI Time Used for Hemostasis (minutes).
Trial Locations
- Locations (19)
Tosei General Hospital
🇯🇵Seto, Aichi, Japan
Shonan Atsugi Hospital
🇯🇵Atsugi, Kanagawa, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Sakurakai Takahashi Hospital
🇯🇵Kobe, Hyogo, Japan
Kyoto Kujo Hospital
🇯🇵Kyoto, Japan
Tokai University
🇯🇵Isehara, Kanagawa, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Jichi Medical University
🇯🇵Shimotsuke, Tochigi, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Cheng Hsin General Hospital
🇨🇳Taipei, Pai-Tou, Taiwan
Shin-Koga Hospital
🇯🇵Kurume, Fukuoka, Japan
Kin-ikyo Central Hospital
🇯🇵Sapporo, Hokkaido, Japan
Chibaken Saiseikai Narashino Hospital
🇯🇵Narashino, Chiba, Japan
Kumamoto Rosai Hospital
🇯🇵Yatsushiro, Kumamoto, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Aomori Prefectural Central Hospital
🇯🇵Aomori, Japan
Fukuoka Heart Clinic
🇯🇵Fukuoka, Japan
Krishna Institute of Medical Sciences
🇮🇳Secunderabad, AP, India
Global Hospital
🇮🇳Hyderabad, AP, India