Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

Overview

The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).

Full Title of Study: “RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2015

Interventions

  • Device: 6Fr Glidesheath Slender sheath
    • 6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.
  • Device: 5Fr sheath
    • 5Fr Hydrophilic coating sheath from Terumo.
  • Procedure: Hemostasis with TR band
    • Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
  • Procedure: Any hemostasis procedure
    • Hemostasis is achieved by any hemostasis of each hospital’s routine procedure.

Arms, Groups and Cohorts

  • Experimental: 6Fr Glidesheath Slender sheath
    • TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).
  • Active Comparator: 5Fr contemporary sheath
    • TRI will be performed using a contemporary safety of 5Fr sheath.
  • Experimental: Hemostasis with TR band
    • Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.
  • Active Comparator: Any hemostasis procedure
    • Hemostasis is achieved by randomization of any hemostasis of each hospital’s routine procedure.

Clinical Trial Outcome Measures

Primary Measures

  • Radial artery occlusion
    • Time Frame: Day 1
  • Local bleeding from puncture site
    • Time Frame: Day 1

Secondary Measures

  • Procedure success rate
    • Time Frame: Day 1
  • Vascular access site complication
    • Time Frame: Day 1
  • Radial spasm during the index procedure
    • Time Frame: Day 1
  • Total Procedure Time
    • Time Frame: Day 1
  • Total Amount of Contrast Dye
    • Time Frame: Day 1
  • Total Radiation Doses
    • Time Frame: Day 1
  • Device failure for the assigned sheath introducer
    • Time Frame: Day 1
  • Pain score
    • Time Frame: Day 1

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB. – Patient who is expected to diagnose by coronary artery angiography or followed by PCI. – Patient must agree to undergo all protocol-required follow-up examinations. – Patient who can accept radial access. Exclusion Criteria:

  • Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). – Hemodialysis patient – STEMI

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NPO International TRI Network
  • Collaborator
    • European Cardiovascular Research Center
  • Provider of Information About this Clinical Study
    • Sponsor

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