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NCT04837404 Clinical Trial

Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Percutaneous Coronary Intervention Clinical Trial

— ULTRACOLOR  

Official title:
Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04837404
Other study ID # 9343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 9, 2021
Est. completion date May 10, 2023

Study information
Verified date June 2023
Source Maatschap Cardiologie Zwolle
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 544
Est. completion date May 10, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound guided femoral access for complex PCI
Ultrasound guided femoral access for complex PCI
• Fluoroscopy guided femoral access for complex PCI
Fluoroscopy guided femoral access for complex PCI

Locations
Country Name City State
Belgium CHU Charleroi Charleroi
Belgium Ziekenhuis Oost Limburg Genk
Belgium Jessa hospital Hasselt
Germany Elisabeth-Krankenhaus Essen
Netherlands Amsterdam UMC Amsterdam
Netherlands Catharina hospital Eindhoven
Netherlands St Antonius Nieuwegein
Netherlands Radboudumc Nijmegen
Netherlands UMC Utrecht Utrecht
Netherlands Isala Hospital Zwolle

Sponsors (2)
Lead Sponsor Collaborator
Maatschap Cardiologie Zwolle Diagram B.V.

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Proportion of patients with MACE up to discharge hospital (on average 24 hours) and at 1 month
Secondary Procedural duration during PCI procedure
Secondary Incidence of first pass puncture during PCI procedure
Secondary Number of access attempts during PCI procedure
Secondary Incidence of.accidental venipuncture during PCI procedure
Secondary Incidence of access below the femoral artery bifurcation (ileofemoral angiogram) during PCI procedure
Secondary 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
Secondary 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
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