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Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

NCT04837404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2023-06-18

No results posted yet for this study

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.

Conditions

  • Complex Coronary Lesions
  • Percutaneous Coronary Intervention

Interventions

PROCEDURE

Ultrasound guided femoral access for complex PCI

Ultrasound guided femoral access for complex PCI

PROCEDURE

Fluoroscopy guided femoral access for complex PCI

Fluoroscopy guided femoral access for complex PCI

Sponsors & Collaborators

  • Diagram B.V.

    collaborator OTHER

  • Maatschap Cardiologie Zwolle

    lead OTHER

Principal Investigators

  • Maarten van Leeuwen, MD, PhD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2023-05-10
Completion
2023-05-10

Countries

  • Belgium
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837404 on ClinicalTrials.gov