Clinical trial NCT04837404: Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
Official title: Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Coronary Lesions
Percutaneous Coronary Intervention
Lead sponsor: Maatschap Cardiologie Zwolle
Sponsor class: OTHER
Collaborators: name: Diagram B.V.
First posted: 2021-04-08
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicentre, randomized investigator-initiated trial with a superiority design
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to discharge hospital, on average 24 hours
Secondary outcomes:
measure: 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.
timeFrame: up to discharge hospital, on average 24 hours
measure: 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.
timeFrame: 1 month
measure: 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
timeFrame: 1 month
measure: Proportion of patients with MACE
timeFrame: up to discharge hospital (on average 24 hours) and at 1 month
measure: Procedural duration
timeFrame: during PCI procedure
measure: Incidence of first pass puncture
timeFrame: during PCI procedure
measure: Number of access attempts
timeFrame: during PCI procedure
measure: Incidence of.accidental venipuncture
timeFrame: during PCI procedure
measure: Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)
timeFrame: during PCI procedure
measure: Incidence of vascular complication not requiring intervention of the primary femoral access site
timeFrame: up to discharge hospital (on average 24 hours) and at 1 month
measure: Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site
timeFrame: up to discharge hospital (on average 24 hours) and at 1 month
Other outcomes:
Locations:
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Hasselt
country: Belgium
facility: Jessa hospital
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Eindhoven
country: Netherlands
facility: Catharina hospital
city: Nieuwegein
country: Netherlands
facility: St Antonius
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala Hospital
Study officials:
affiliation: Isala
name: Maarten van Leeuwen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: