Patency of the Radial Artery Clinical Trial
— NAUSICAOfficial title:
Novel Angioplasty USIng Coronary Accessor
| Verified date | February 2019 |
| Source | NAUSICA Investigators |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | December 31, 2010 |
| Est. primary completion date | December 31, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| India | Global Hospital | Hyderabad | AP |
| India | Krishna Institute of Medical Sciences | Secunderabad | AP |
| Japan | Aomori Prefectural Central Hospital | Aomori | |
| Japan | Shonan Atsugi Hospital | Atsugi | Kanagawa |
| Japan | Fukuoka Heart Clinic | Fukuoka | |
| Japan | Tokai University | Isehara | Kanagawa |
| Japan | Shonan Kamakura General Hospital | Kamakura | Kanagawa |
| Japan | Sakurakai Takahashi Hospital | Kobe | Hyogo |
| Japan | Shin-Koga Hospital | Kurume | Fukuoka |
| Japan | Kyoto Kujo Hospital | Kyoto | |
| Japan | Chibaken Saiseikai Narashino Hospital | Narashino | Chiba |
| Japan | Hyogo College of Medicine | Nishinomiya | Hyogo |
| Japan | Kin-ikyo Central Hospital | Sapporo | Hokkaido |
| Japan | Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido |
| Japan | Tosei General Hospital | Seto | Aichi |
| Japan | Jichi Medical University | Shimotsuke | Tochigi |
| Japan | Kumamoto Rosai Hospital | Yatsushiro | Kumamoto |
| Japan | Yokohama City University Medical Center | Yokohama | Kanagawa |
| Taiwan | Cheng Hsin General Hospital | Taipei | Pai-Tou |
| Lead Sponsor | Collaborator |
|---|---|
| NAUSICA Investigators | NPO International TRI Network |
India, Japan, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Radial Artery Occlusion | 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. | within 2 days after TRI | |
| Secondary | Number of Patients With Successful PCI | 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. | within 2 days after TRI | |
| Secondary | Number of Patients With Measure Adverse Cardiac Event (MACE) | Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization | within 2 days after TRI | |
| Secondary | Number of Patients With Access-site Complications | 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. | within 2 days after TRI | |
| Secondary | Fluoroscopy Time Used for the Procedure | Fluoroscopy time used for the procedure (minutes). | At the end of TRI | |
| Secondary | Contrast Dye Volume Used for the Procedure | Contrast dye volume used for the procedure (mL). | At the end of TRI | |
| Secondary | Time Used for the Procedure | Time used for the procedure (minutes). | At the end of TRI | |
| Secondary | Time Used for Hemostasis | Time Used for Hemostasis (minutes). | within 2 days afterTRI |