TRASOUND GUIDED TRANSFEMORAL COMPLEX LARGE-BORE PCI TRIA

Recruiting

• Conditions: atherosclerosis; complex coronary lesion; 10011082

• Registration Number: NL-OMON51199
• Lead Sponsor: Maatschap Cardiologie Isala Zwolle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

1) Use of the femoral artery for primary or secondary access with >= 7 Fr
guiding catheter as indication 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 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>To investigate if ultrasound guided primary femoral access is associated with<br /><br>less clinically relevant access site related bleeding (BARC 2,3 or 5) and/or<br /><br>vascular complication requiring intervention as compared to fluoroscopy guided<br /><br>cannulation for complex PCI with large-bore access.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare ultrasound guided with fluoroscopy guided femoral access for complex<br /><br>PCI with large-bore access with regard to the following objectives (definitions<br /><br>in appendix I):<br /><br>- BARC 2, 3 or 5 access-site related bleeding or vascular complication of<br /><br>secondary access site (femoral or radial, defined in appendix I)<br /><br>- MACE<br /><br>- Procedural duration<br /><br>- First pass puncture<br /><br>- Accidental venous puncture<br /><br>- Vascular complication not requiring intervention<br /><br>- Vascular closure device failure</p><br>