Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial (Color)
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|ClinicalTrials.gov Identifier: NCT03846752|
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : August 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Complex Coronary Lesions||Procedure: radial artery access for complex PCI Procedure: femoral artery access for complex PCI||Not Applicable|
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.
|Study Type :||Interventional|
|Actual Enrollment :||388 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI|
|Actual Study Start Date :||March 5, 2019|
|Actual Primary Completion Date :||April 22, 2020|
|Actual Study Completion Date :||May 20, 2020|
Active Comparator: 7 Fr. radial access
radial artery access for complex PCI
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.
Active Comparator: 7 Fr. femoral access
femoral artery access for complex PCI
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.
- 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). [ Time Frame: PCI procedure till patients is discharged from the hospital, with a maximum of 30 days ]The primary endpoint is defined as BARC 2,3 and 5 bleeding or vascular complication related to the randomized access site (during hospitalization).
- Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization) [ Time Frame: PCI procedure till patients is discharged from the hospital, with a maximum of 30 days ]Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization)
- MACE (hospitalization and 1-month) [ Time Frame: PCI procedure till 30 days after PCI procedure ]MACE: Composite of death, myocardial infarction and repeat revascularization
- Procedural success [ Time Frame: during PCI procedure ]Successful PCI of the target lesion with a residual stenosis of less than 20%
- procedural time [ Time Frame: during PCI procedure ]Procedural time from puncture to end procedure (in minutes)
- fluoroscopy time [ Time Frame: during PCI procedure ]fluoroscopy time (in seconds)
- contrast use [ Time Frame: during PCI procedure ]Contrast volume used (in ml)
- crossover rate [ Time Frame: during PCI procedure ]Failure to complete the procedure through the randomized access site, requiring conversion from radial to femoral access or vice versa for procedure completion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846752
|Ziekenhuis Oost Limburg|
|Zwolle, Overijssel, Netherlands|
|Catharina Ziekenhuis Eindhoven|
|University Hospital Geneva|
|Frimley Health NHS Foundation Trust, Surrey|
|Camberley, United Kingdom|
|Principal Investigator:||Maarten A. Van Leeuwen, MD||Isala|