Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

NCT02269449 | Unknown DMC

• 1 other identifier: TRI20140920
• Study Type: interventional
• Target: 1,900
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Percutaneous Coronary Intervention

Keywords

transradial intervention; radial artery

Outcome Measures

Primary Outcomes (2)

• Radial artery occlusion

  Day 1

• Local bleeding from puncture site

  Day 1

Secondary Outcomes (8)

• Procedure success rate

  Day 1

• Vascular access site complication

  Day 1

• Radial spasm during the index procedure

  Day 1

• Total Procedure Time

  Day 1

• Total Amount of Contrast Dye

  Day 1

Study Arms (4)

6Fr Glidesheath Slender sheath

EXPERIMENTAL

TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS).

Device: 6Fr Glidesheath Slender sheath

5Fr contemporary sheath

ACTIVE COMPARATOR

TRI will be performed using a contemporary safety of 5Fr sheath.

Device: 5Fr sheath

Hemostasis with TR band

EXPERIMENTAL

Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis.

Procedure: Hemostasis with TR band

Any hemostasis procedure

ACTIVE COMPARATOR

Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure.

Procedure: Any hemostasis procedure

Interventions

6Fr Glidesheath Slender sheath DEVICE

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.

6Fr Glidesheath Slender sheath

5Fr sheath DEVICE

5Fr Hydrophilic coating sheath from Terumo.

5Fr contemporary sheath

Hemostasis with TR band PROCEDURE

Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.

Hemostasis with TR band

Any hemostasis procedure PROCEDURE

Hemostasis is achieved by any hemostasis of each hospital's routine procedure.

Any hemostasis procedure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NPO International TRI Network: lead
• European Cardiovascular Research Center: collaborator
• Duke Clinical Research Institute: collaborator

MeSH Terms

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 21, 2014

Record last verified: 2014-10