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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Complex Coronary Lesions
• Percutaneous Coronary Intervention

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