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Completed

NCT Number: NCT04837404

Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

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.

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Key information

Conditions

Complex Coronary Lesions Percutaneous Coronary Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Charleroi, Charleroi, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided femoral access for complex PCI

Procedure

Ultrasound guided femoral access for complex PCI

Fluoroscopy guided femoral access for complex PCI

Procedure

Fluoroscopy guided femoral access for complex PCI

Primary outcomes

  1. 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.

    Time frame: up to discharge hospital, on average 24 hours

Secondary outcomes

  1. 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.

    Time frame: up to discharge hospital, on average 24 hours

  2. 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.

    Time frame: 1 month

  3. 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

    Time frame: 1 month

  4. Proportion of patients with MACE

    Time frame: up to discharge hospital (on average 24 hours) and at 1 month

  5. Procedural duration

    Time frame: during PCI procedure

  6. Incidence of first pass puncture

    Time frame: during PCI procedure

  7. Number of access attempts

    Time frame: during PCI procedure

  8. Incidence of.accidental venipuncture

    Time frame: during PCI procedure

  9. Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)

    Time frame: during PCI procedure

  10. Incidence of vascular complication not requiring intervention of the primary femoral access site

    Time frame: up to discharge hospital (on average 24 hours) and at 1 month

  11. Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site

    Time frame: up to discharge hospital (on average 24 hours) and at 1 month

Sponsors and collaborators

Lead sponsor

Maatschap Cardiologie Zwolle

Other

Collaborators

  • Diagram B.V.

Registry information

Acronym: ULTRACOLOR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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