COMPLEX LARGE-BORE RADIAL PCI TRIA

Completed

• Conditions: atherosclerosis; complex coronary lesion; 10011082

• Registration Number: NL-OMON48821
• Lead Sponsor: Maatschap cardiologie, Zwolle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 236

Inclusion Criteria

1) Use of 7 Fr guiding catheter is indicated for complex PCI, according to the
expertise of the treating
physician.
2) Age 18 years or older

Exclusion Criteria

1) Inability to obtain informed consent
2) contra-indication for radial or femoral access
3) Cardiogenic shock
4) ST elevation myocardial infarction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is defined as BARC type 2, 3 or 5 bleeding or vascular<br /><br>complication related to the randomized access site (during hospitalization).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are defined as:<br /><br>1) Non-access site related BARC type 2, 3 or 5 bleeding and/or vascular<br /><br>complications (hospitalization)<br /><br>2) MACE (hospitalization and 1-month)<br /><br>3) Procedural success, procedural time, fluoroscopy time, contrast use and<br /><br>crossover rate</p><br>