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

Maatschap Cardiologie Zwolle

Status: Completed

Conditions: Complex Coronary Lesions

Treatments: Procedure: femoral artery access for complex PCI; Procedure: radial artery access for complex PCI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03846752

9285

NL66831.075.18 (Registry Identifier)

180716 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

During hospitalization (before discharge) the access site(s) will be checked for bleeding and vascular complications. All access sites should be checked for absent pulsations and hematomas and the size should be defined (length and width, cm) and accompanied complaints. Radial artery occlusion should be checked with the reverse Barbeau test. The femoral access site should be checked for murmurs and absence of pulsations. Ultrasound or Doppler of the access sites should be performed in those patients with suspected radial or femoral occlusion and the presence of other vascular complications, like (pseudo) aneurysms or arteriovenous (AV) fistula within 1 month.

Patient-reported extremity dysfunction will be evaluated at baseline (before the procedure) and 1-month follow-up. Upper extremity function will be evaluated with the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and lower extremity function with Lower Extremity Functional Scale questionnaire (LEFS). The occurrence of Major Adverse Cardiac Events (MACE) will be evaluated at discharge and 1-month follow-up.

Enrollment: 388 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Use of 7 Fr guiding catheter is indicated 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 radial or 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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388 participants in 2 patient groups

7 Fr. radial access

Active Comparator group

Description:

radial artery access for complex PCI

Treatment:

Procedure: radial artery access for complex PCI

7 Fr. femoral access

Active Comparator group

Description:

femoral artery access for complex PCI

Treatment:

Procedure: femoral artery access for complex PCI