Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2023-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Physiology to Evaluate Procedural Result After PCI CTO

NCT04780971

Percutaneous Coronary Revascularisation Complex Coronary Lesion

RECRUITING NA

Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction

NCT05974930

STEMI Intravascular Imaging IVUS

NOT_YET_RECRUITING

Intravascular Ultrasound (IVUS) in Complex Aortic Endovascular Interventions

NCT04663074

Thoracic Aortic Aneurysm

COMPLETED

The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions

NCT05621421

Coronary Artery Disease

COMPLETED

QFR-based Virtual PCI Versus Angio-guided PCI

NCT04664140

Percutaneous Coronary Intervention Coronary Physiology

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complex Coronary Lesions Percutaneous Coronary Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multicentre, randomized investigator-initiated trial with a superiority design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ultrasound guided femoral access

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

Group Type OTHER

Ultrasound guided femoral access for complex PCI

Intervention Type PROCEDURE

Ultrasound guided femoral access for complex PCI

fluoroscopy guided femoral access

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

Group Type OTHER

Fluoroscopy guided femoral access for complex PCI

Intervention Type PROCEDURE

Fluoroscopy guided femoral access for complex PCI

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound guided femoral access for complex PCI

Intervention Type PROCEDURE

Fluoroscopy guided femoral access for complex PCI

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.