NCT04837404

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.9 years

First QC Date

March 1, 2021

Last Update Submit

June 15, 2023

Conditions

Complex Coronary LesionsPercutaneous Coronary Intervention

Outcome Measures

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.

    up to discharge hospital, on average 24 hours

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

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.

Procedure: Ultrasound guided femoral access for complex PCI

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.

Procedure: Fluoroscopy guided femoral access for complex PCI

Interventions

Ultrasound guided femoral access for complex PCIPROCEDURE

Ultrasound guided femoral access for complex PCI

ultrasound guided femoral access
Fluoroscopy guided femoral access for complex PCIPROCEDURE

Fluoroscopy guided femoral access for complex PCI

fluoroscopy guided femoral access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to obtain informed consent
  • Contra-indication for femoral access
  • Cardiogenic shock
  • ST elevation myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Charleroi

Charleroi, Belgium

Location

Ziekenhuis Oost Limburg

Genk, Belgium

Location

Jessa hospital

Hasselt, Belgium

Location

Elisabeth-Krankenhaus

Essen, Germany

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Catharina hospital

Eindhoven, Netherlands

Location

St Antonius

Nieuwegein, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Isala Hospital

Zwolle, 8025 AB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 38742577DERIVED

Study Officials

  • Maarten van Leeuwen, MD, PhD

    Isala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multicentre, randomized investigator-initiated trial with a superiority design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

April 8, 2021

Study Start

June 9, 2021

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

DE(1)NL(6)BE(3)