Complex Coronary Lesions, Percutaneous Coronary Intervention
Conditions
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 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.
Interventions
PROCEDUREUltrasound guided femoral access for complex PCI
Ultrasound guided femoral access for complex PCI
PROCEDUREFluoroscopy guided femoral access for complex PCI
Fluoroscopy guided femoral access for complex PCI
Sponsors
Diagram B.V.
Maatschap Cardiologie Zwolle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicentre, randomized investigator-initiated trial with a superiority design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | up to discharge hospital, on average 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of access attempts | during PCI procedure |
| Incidence of.accidental venipuncture | during PCI procedure |
| 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. | 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. | 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 | 1 month |
| Incidence of first pass puncture | during PCI procedure |
| Procedural duration | during PCI procedure |
| Incidence of access below the femoral artery bifurcation (ileofemoral angiogram) | during PCI procedure |
| Incidence of vascular complication not requiring intervention of the primary femoral access site | 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 | up to discharge hospital (on average 24 hours) and at 1 month |
| Proportion of patients with MACE | up to discharge hospital (on average 24 hours) and at 1 month |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed