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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
544
Ultrasound guided femoral access for complex PCI
Fluoroscopy guided femoral access for complex PCI
CHU Charleroi
Charleroi, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
Jessa hospital
Hasselt, Belgium
Elisabeth-Krankenhaus
Essen, Germany
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.
Time frame: up to discharge hospital, on average 24 hours
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization.
Time frame: up to discharge hospital, on average 24 hours
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month.
Time frame: 1 month
Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month
Time frame: 1 month
Proportion of patients with MACE
Time frame: up to discharge hospital (on average 24 hours) and at 1 month
Procedural duration
Time frame: during PCI procedure
Incidence of first pass puncture
Time frame: during PCI procedure
Number of access attempts
Time frame: during PCI procedure
Incidence of.accidental venipuncture
Time frame: during PCI procedure
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Amsterdam UMC
Amsterdam, Netherlands
Catharina hospital
Eindhoven, Netherlands
St Antonius
Nieuwegein, Netherlands
Radboudumc
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Isala Hospital
Zwolle, Netherlands
Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)
Time frame: during PCI procedure
Incidence of vascular complication not requiring intervention of the primary femoral access site
Time frame: up to discharge hospital (on average 24 hours) and at 1 month
Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site
Time frame: up to discharge hospital (on average 24 hours) and at 1 month