NCT04837404

Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 544 (actual)
• Sponsor: Maatschap Cardiologie Zwolle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.

Detailed description

ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions. This study will investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.

Conditions

• Complex Coronary Lesions
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	Ultrasound guided femoral access for complex PCI	Ultrasound guided femoral access for complex PCI
PROCEDURE	Fluoroscopy guided femoral access for complex PCI	Fluoroscopy guided femoral access for complex PCI

Timeline

• Start date: 2021-06-09
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2021-04-08
• Last updated: 2023-06-18

Locations

10 sites across 3 countries: Belgium, Germany, Netherlands