Status:
COMPLETED
Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
Lead Sponsor:
Maatschap Cardiologie Zwolle
Collaborating Sponsors:
Diagram B.V.
Conditions:
Complex Coronary Lesions
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 v...
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 ...
Eligibility Criteria
Inclusion
- 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.
- Age 18 years or older.
Exclusion
- Inability to obtain informed consent
- Contra-indication for femoral access
- Cardiogenic shock
- ST elevation myocardial infarction
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2023
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT04837404
Start Date
June 9 2021
End Date
May 10 2023
Last Update
June 18 2023
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Charleroi
Charleroi, Belgium
2
Ziekenhuis Oost Limburg
Genk, Belgium
3
Jessa hospital
Hasselt, Belgium
4
Elisabeth-Krankenhaus
Essen, Germany