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Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial (RAPandBEAT)

Primary Purpose

Percutaneous Coronary Intervention

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

6Fr Glidesheath Slender sheath

5Fr sheath

Hemostasis with TR band

Any hemostasis procedure

About this trial

This is an interventional supportive care trial for Percutaneous Coronary Intervention focused on measuring transradial intervention, radial artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

6Fr Glidesheath Slender sheath

5Fr contemporary sheath

Hemostasis with TR band

Any hemostasis procedure

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Radial artery occlusion

Local bleeding from puncture site

Secondary Outcome Measures

Procedure success rate

Vascular access site complication

Radial spasm during the index procedure

Total Procedure Time

Total Amount of Contrast Dye

Total Radiation Doses

Device failure for the assigned sheath introducer

Pain score

Full Information

NCT ID

NCT02269449

First Posted

October 7, 2014

Last Updated

October 16, 2014

Sponsor

NPO International TRI Network

Collaborators

European Cardiovascular Research Center, Duke Clinical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02269449

Brief Title

Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

Acronym

RAPandBEAT

Official Title

RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NPO International TRI Network

Collaborators

European Cardiovascular Research Center, Duke Clinical Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Percutaneous Coronary Intervention

Keywords

transradial intervention, radial artery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

6Fr Glidesheath Slender sheath

Arm Type

Experimental

Arm Description

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

Arm Title

5Fr contemporary sheath

Arm Type

Active Comparator

Arm Description

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

Arm Title

Hemostasis with TR band

Arm Type

Experimental

Arm Description

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

Arm Title

Any hemostasis procedure

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

6Fr Glidesheath Slender sheath

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

5Fr sheath

Intervention Description

5Fr Hydrophilic coating sheath from Terumo.

Intervention Type

Procedure

Intervention Name(s)

Hemostasis with TR band

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Any hemostasis procedure

Intervention Description

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

Primary Outcome Measure Information:

Title

Radial artery occlusion

Time Frame

Day 1

Title

Local bleeding from puncture site

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Procedure success rate

Time Frame

Day 1

Title

Vascular access site complication

Time Frame

Day 1

Title

Radial spasm during the index procedure

Time Frame

Day 1

Title

Total Procedure Time

Time Frame

Day 1

Title

Total Amount of Contrast Dye

Time Frame

Day 1

Title

Total Radiation Doses

Time Frame

Day 1

Title

Device failure for the assigned sheath introducer

Time Frame

Day 1

Title

Pain score

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial

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