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

Phase 3

Completed

Conditions: radial artery occlusion occlusie van de a. radialis
10011082

Registration Number: NL-OMON42483

Lead Sponsor: PO International TRI Network, Research Center, Cardiovascular Dept., Shonan Kamakura General hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

5.4 General Inclusion Criteria
1. Patient must be at least 18 years of age.
2. Patient is able to verbally acknowledge an understanding of the associated risks, benefits
and treatment alternatives
3. Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
4. Patient must agree to undergo all protocol-required follow-up examinations.
5. Patient who can accept radial access.

Exclusion Criteria

1. 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).
2. Hemodialysis patient
3. STEMI

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is composite of the freedom from radial artery occlusion<br /><br>(RAO) and local bleeding from the puncture site at the time of discharge or<br /><br>the next day, the earlier of the two.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Procedure success rate at the index procedure.<br /><br>* Vascular access site complication<br /><br>* Radial spasm during the index procedure.<br /><br>* Total Procedure Time<br /><br>* Total Amount of Contrast Dye<br /><br>* Fluoroscope time<br /><br>* Procedure failure due to the assigned sheath.<br /><br>* Pain score</p><br>