Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Complex Coronary Lesions
- Percutaneous Coronary Intervention
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, multicentre, randomized investigator-initiated trial with a superiority designMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 b...
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.
Tracking Information
- NCT #
- NCT04837404
- Collaborators
- Diagram B.V.
- Investigators
- Principal Investigator: Maarten van Leeuwen, MD, PhD Isala
Get Well Soon