MedTrace Logo

Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial

NCT03846752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2020-08-18

No results posted yet for this study

Summary

The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomized in a 1:1 fashion between the two study treatments, (7 Fr. radial access with a Glideslender sheath or 7 Fr. femoral access with a standard femoral sheath) , in a 1:1 ratio.

Conditions

  • Complex Coronary Lesions

Interventions

PROCEDURE

radial artery access for complex PCI

Complex PCI with access via radial artery using a 7 Fr. Glideslender sheath. PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.

PROCEDURE

femoral artery access for complex PCI

Complex PCI with access via femoral artery using a 7 Fr. standard femoral sheath . PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.

Sponsors & Collaborators

  • Terumo Europe N.V.

    collaborator INDUSTRY

  • Maatschap Cardiologie Zwolle

    lead OTHER

Principal Investigators

  • Maarten A. Van Leeuwen, MD · Isala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-05
Primary Completion
2020-04-22
Completion
2020-05-20

Countries

  • Belgium
  • Germany
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846752 on ClinicalTrials.gov