Ultrasound Guided Transfemoral Complex Large-bore PCI Trial (ULTRACOLOR)

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Complex Coronary Lesions
• Intervention / Treatment: Procedure: Ultrasound guided femoral access for complex PCI; Procedure: Fluoroscopy guided femoral access for complex PCI

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.

• Study Type: Interventional
• Enrollment (Actual): 544
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium
    • CHU Charleroi
  • Genk, Belgium
    • Ziekenhuis Oost Limburg
  • Hasselt, Belgium
    • Jessa Hospital
• Germany
  • Essen, Germany
    • Elisabeth-Krankenhaus
• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC
  • Eindhoven, Netherlands
    • Catharina Hospital
  • Nieuwegein, Netherlands
    • St Antonius
  • Nijmegen, Netherlands
    • Radboudumc
  • Utrecht, Netherlands
    • UMC Utrecht
  • Zwolle, Netherlands, 8025 AB
    • Isala Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ultrasound guided femoral access; 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; Ultrasound guided femoral access for complex PCI
Other: fluoroscopy guided femoral access; 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; Fluoroscopy guided femoral access for complex PCI

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Maatschap Cardiologie Zwolle
• Collaborators: Diagram B.V.
• Investigators: Principal Investigator: Maarten van Leeuwen, MD, PhD, Isala

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 9343 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No