Novel Angioplasty Using Coronary Accessor

NCT00815997 | Completed Results DMC

• 1 other identifier: 2008-28
• Study Type: interventional
• Target: 160
• Locations: 3 countries
• Sites: 19

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.

Conditions

Patency of the Radial Artery

Keywords

radial artery; transradial intervention; stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Patients With Successful PCI

  within 2 days after TRI

• Number of Patients With Measure Adverse Cardiac Event (MACE)

  within 2 days after TRI

• Number of Patients With Access-site Complications

  within 2 days after TRI

• Fluoroscopy Time Used for the Procedure

  At the end of TRI

• Contrast Dye Volume Used for the Procedure

  At the end of TRI

Study Arms (2)

6-Fr TRI (transradial coronary intervention)

SHAM COMPARATOR

TRI will be performed using a 6-Fr guiding catheter.

Procedure: PCI (percutaneous coronary intervention)

4-Fr TRI

ACTIVE COMPARATOR

TRI will be performed using a 4-Fr guiding catheter.

Procedure: PCI (percutaneous coronary intervention)

Interventions

PCI (percutaneous coronary intervention) PROCEDURE

PCI will be performed via the radial artery.

4-Fr TRI; 6-Fr TRI (transradial coronary intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NAUSICA Investigators: lead
• NPO International TRI Network: collaborator

Study Sites (19)

Global Hospital

Hyderabad, Andhra Pradesh, India

Location

Krishna Institute of Medical Sciences

Secunderabad, Andhra Pradesh, 500003, India

Location

Tosei General Hospital

Seto, Aichi-ken, 489-8652, Japan

Location

Chibaken Saiseikai Narashino Hospital

Narashino, Chiba, 275-0006, Japan

Location

Shin-Koga Hospital

Kurume, Fukuoka, 830-8577, Japan

Location

Kin-ikyo Central Hospital

Sapporo, Hokkaido, 007-8505, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, 065-0033, Japan

Location

Sakurakai Takahashi Hospital

Kobe, Hyōgo, 654-0026, Japan

Location

Hyogo College of Medicine

Nishinomiya, Hyōgo, 665-8501, Japan

Location

Shonan Atsugi Hospital

Atsugi, Kanagawa, 243-8551, Japan

Location

Tokai University

Isehara, Kanagawa, 259-1193, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Kumamoto Rosai Hospital

Yatsushiro, Kumamoto, 866-8533, Japan

Location

Jichi Medical University

Shimotsuke, Tochigi, 329-0498, Japan

Location

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

Location

Fukuoka Heart Clinic

Fukuoka, 813-0036, Japan

Location

Kyoto Kujo Hospital

Kyoto, 601-8453, Japan

Location

Cheng Hsin General Hospital

Taipei, Pai-Tou, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24786357 DERIVED

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Sigeru Saito, MD, Principal Investigator
• Organization: NPO International TRI Network

saito@shonankamakura.or.jp

+81-467-461717

Study Officials

• Shigeru Saito, MD

  Vice Preseident, Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Shonan Kamakura Genaral Hospital

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 31, 2008
• Study Start: January 1, 2009
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2010
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

JP (16); TW (1); IN (2)