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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI

Conditions
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Complex Coronary Lesions

Intervention / Treatment
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* Procedure: radial artery access for complex PCI
* Procedure: femoral artery access for complex PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician. Age 18 years or older. Exclusion Criteria: Inability to obtain informed consent contra-indication for radial or femoral access Cardiogenic shock ST-elevation myocardial infarction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7 Fr. radial access<br>radial artery access for complex PCI | Procedure: radial artery access for complex PCI<br>* 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.<br>|
| Active Comparator: 7 Fr. femoral access<br>femoral artery access for complex PCI | Procedure: femoral artery access for complex PCI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is defined as BARC 2,3 and 5 (Bleeding Academic Research Consortium) bleeding or vascular complication related to the randomized access site (during hospitalization). | The primary endpoint is defined as BARC 2,3 and 5 bleeding or vascular complication related to the randomized access site (during hospitalization). | PCI procedure till patients is discharged from the hospital, with a maximum of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization) | Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization) | PCI procedure till patients is discharged from the hospital, with a maximum of 30 days | 
| MACE (hospitalization and 1-month) | MACE: Composite of death, myocardial infarction and repeat revascularization | PCI procedure till 30 days after PCI procedure | 
| Procedural success | Successful PCI of the target lesion with a residual stenosis of less than 20% | during PCI procedure | 
| procedural time | Procedural time from puncture to end procedure (in minutes) | during PCI procedure | 
| fluoroscopy time | fluoroscopy time (in seconds) | during PCI procedure | 
| contrast use | Contrast volume used (in ml) | during PCI procedure | 
| crossover rate | Failure to complete the procedure through the randomized access site, requiring conversion from radial to femoral access or vice versa for procedure completion | during PCI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transradial Intervention, transfemoral intervention, PCI for complex coronary lesions