Ultrasound Guided Transfemoral Complex Large-bore PCI Trial (ULTRACOLOR)

Maatschap Cardiologie Zwolle

Status: Completed

Conditions: Complex Coronary Lesions; Percutaneous Coronary Intervention

Treatments: Procedure: Fluoroscopy guided femoral access for complex PCI; Procedure: Ultrasound guided femoral access for complex PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT04837404

9343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 544 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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544 participants in 2 patient groups

ultrasound guided femoral access

Other group

Description:

Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used.

Treatment:

Procedure: Ultrasound guided femoral access for complex PCI

fluoroscopy guided femoral access

Other group

Description:

Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used.

Treatment:

Procedure: Fluoroscopy guided femoral access for complex PCI