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| Name | Class |
|---|---|
| Diagram B.V. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound guided femoral access | Other | Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used. |
|
| fluoroscopy guided femoral access | Other | Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided femoral access for complex PCI | Procedure | Ultrasound guided femoral access for complex PCI |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten van Leeuwen, MD, PhD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Charleroi | Charleroi | Belgium | ||||
| Ziekenhuis Oost Limburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38742577 | Derived | Meijers TA, Nap A, Aminian A, Schmitz T, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Bataille Y, Kraaijeveld AO, Roolvink V, Dambrink JE, Gosselink ATM, Hermanides RS, Ottervanger JP, Tsilingiris I, van den Buijs DMF, van Royen N, van Leeuwen MAH. Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial. EuroIntervention. 2024 Jul 15;20(14):e876-e886. doi: 10.4244/EIJ-D-24-00089. |
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Prospective, multicentre, randomized investigator-initiated trial with a superiority design
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| Fluoroscopy guided femoral access for complex PCI | Procedure | Fluoroscopy guided femoral access for complex PCI |
|
| 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 |
| Proportion of patients with MACE | up to discharge hospital (on average 24 hours) and at 1 month |
| Procedural duration | during PCI procedure |
| Incidence of first pass puncture | during PCI procedure |
| Number of access attempts | during PCI procedure |
| Incidence of.accidental venipuncture | 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 |
| Genk |
| Belgium |
| Jessa hospital | Hasselt | Belgium |
| Elisabeth-Krankenhaus | Essen | Germany |
| Amsterdam UMC | Amsterdam | Netherlands |
| Catharina hospital | Eindhoven | Netherlands |
| St Antonius | Nieuwegein | Netherlands |
| Radboudumc | Nijmegen | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Isala Hospital | Zwolle | 8025 AB | Netherlands |