Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Conditions
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Complex Coronary Lesions, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Ultrasound guided femoral access for complex PCI
* Procedure: Fluoroscopy guided femoral access for complex PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Inability to obtain informed consent Contra-indication for femoral access Cardiogenic shock ST elevation myocardial infarction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicentre, randomized investigator-initiated trial with a superiority design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ultrasound guided femoral access<br>Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used. | Procedure: Ultrasound guided femoral access for complex PCI<br>* Ultrasound guided femoral access for complex PCI<br>|
| Other: fluoroscopy guided femoral access<br>Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used. | Procedure: Fluoroscopy guided femoral access for complex PCI<br>* Fluoroscopy guided femoral access for complex PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |