Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Ultrasound Guided Transfemoral Complex Large-bore PCI Trial

Sponsors

Lead Sponsor: Maatschap Cardiologie Zwolle

Collaborator: Diagram B.V.

Source Maatschap Cardiologie Zwolle
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.

Overall Status Recruiting
Start Date 2021-06-09
Completion Date 2024-12-31
Primary Completion Date 2024-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
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
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
Proportion of patients with MACE up to discharge hospital (on average 24 hours) and at 1 month
Procedural duration during PCI procedure
Incidence of first pass puncture during PCI procedure
Number of access attempts during PCI procedure
Incidence of.accidental venipuncture during PCI procedure
Incidence of access below the femoral artery bifurcation (ileofemoral angiogram) during PCI procedure
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
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
Enrollment 542
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Ultrasound guided femoral access for complex PCI

Description: Ultrasound guided femoral access for complex PCI

Arm Group Label: ultrasound guided femoral access

Intervention Type: Procedure

Intervention Name: Fluoroscopy guided femoral access for complex PCI

Description: Fluoroscopy guided femoral access for complex PCI

Arm Group Label: fluoroscopy guided femoral 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Maarten van Leeuwen, MD, PhD Principal Investigator Isala
Overall Contact

Last Name: Jolanda Pol-van der Velde, MSc

Phone: +31 (0)38 426 2999

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Isala Hospital Maarten van Leeuwen, MD, PhD +31 38 424 50 00 [email protected] Maarten van Leeuwen, MD, PhD Principal Investigator Tom Meijers, MD Sub-Investigator
Location Countries

Netherlands

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: ultrasound guided femoral access

Type: Other

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

Label: fluoroscopy guided femoral access

Type: Other

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

Acronym ULTRACOLOR
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Prospective, multicentre, randomized investigator-initiated trial with a superiority design

Primary Purpose: Treatment

Masking: None (Open Label)

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