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NCT04837404: ULTRACOLOR

Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Completed NA Last updated 18 June 2023
What this trial tests

NA trial testing Ultrasound guided femoral access for complex PCI in Complex Coronary Lesions in 544 participants. Completed in 10 May 2023.

Timeline
9 June 2021
Primary endpoint
10 May 2023
10 May 2023

Quick facts

Lead sponsorMaatschap Cardiologie Zwolle
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment544
Start date9 June 2021
Primary completion10 May 2023
Estimated completion10 May 2023
Sites10 locations across Belgium, Netherlands, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Maatschap Cardiologie Zwolle — full company profile →

Who can join

18 and older, any sex, with Complex Coronary Lesions or Percutaneous Coronary Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Same-day discharge after large-bore access in percutaneous coronary intervention of chronic total coronary occlusions.
    Somsen YBO, Wilgenhof A, Hoek R, Schumacher SP, et al · · 2024 · cited 9× · PMID 38776144 · DOI 10.4244/eij-d-23-00838
  2. ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial.
    Meijers TA, Nap A, Aminian A, Dens J, et al · · 2022 · cited 9× · PMID 36456007 · DOI 10.1136/bmjopen-2022-065693
  3. Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial.
    Meijers TA, Nap A, Aminian A, Schmitz T, et al · · 2024 · cited 7× · PMID 38742577 · DOI 10.4244/eij-d-24-00089

Verify or expand the search:

Other recruiting trials for Complex Coronary Lesions

Currently open trials in the same condition.

Other Maatschap Cardiologie Zwolle trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04837404.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing