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

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

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.

Study Overview

• Status: Completed
• Conditions: Complex Coronary Lesions
• Intervention / Treatment: Procedure: radial artery access for complex PCI; Procedure: femoral artery access for complex PCI

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • ZNA Middelheim
  • Charleroi, Belgium
    • Chu Charleroi
  • Genk, Belgium
    • Ziekenhuis Oost Limburg
• Germany
  • Essen, Germany
    • Elisabeth Krankenhaus
• Netherlands
  • Alkmaar, Netherlands
    • Noordwest Ziekenhuisgroep
  • Amsterdam, Netherlands
    • OLVG
  • Amsterdam, Netherlands
    • VUMC
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis Eindhoven
  • Nijmegen, Netherlands
    • Radboudumc
  • Overijssel
    • Zwolle, Overijssel, Netherlands
      • Isala
• Switzerland
  • Geneva, Switzerland
    • University Hospital Geneva
• United Kingdom
  • Camberley, United Kingdom
    • Frimley Health NHS Foundation Trust, Surrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maatschap Cardiologie Zwolle
• Collaborators: Terumo Europe N.V.
• Investigators: Principal Investigator: Maarten A. Van Leeuwen, MD, Isala

Publications and helpful links

General Publications

• Meijers TA, Aminian A, van Wely M, Teeuwen K, Schmitz T, Dirksen MT, Rathore S, van der Schaaf RJ, Knaapen P, Dens J, Iglesias JF, Agostoni P, Roolvink V, Lemmert ME, Hermanides RS, van Royen N, van Leeuwen MAH. Extremity Dysfunction After Large-Bore Radial and Femoral Arterial Access. J Am Heart Assoc. 2022 Jan 18;11(2):e023691. doi: 10.1161/JAHA.121.023691. Epub 2022 Jan 13.
• Meijers TA, Aminian A, van Wely M, Teeuwen K, Schmitz T, Dirksen MT, Rathore S, van der Schaaf RJ, Knaapen P, Dens J, Iglesias JF, Agostoni P, Roolvink V, Hermanides RS, van Royen N, van Leeuwen MAH. Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1293-1303. doi: 10.1016/j.jcin.2021.03.041. Epub 2021 May 18.
• Meijers TA, Aminian A, Teeuwen K, van Wely M, Schmitz T, Dirksen MT, van der Schaaf RJ, Iglesias JF, Agostoni P, Dens J, Knaapen P, Rathore S, Ottervanger JP, Dambrink JE, Roolvink V, Gosselink ATM, Hermanides RS, van Royen N, van Leeuwen MAH. Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol. BMJ Open. 2020 Jul 20;10(7):e038042. doi: 10.1136/bmjopen-2020-038042.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): April 22, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Transradial Intervention; transfemoral intervention; PCI for complex coronary lesions
• Other Study ID Numbers: 9285; NL66831.075.18 (Registry Identifier: CCMO); 180716 (Other Identifier: Dutch ethical committe)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The availability of individual participant data will be separately decided for each request by the PI of the study. The sponsor will have to agree before publication.

All data that is required to minimally fulfill the request will be shared.

• IPD Sharing Time Frame: Data is available after publication of final specific subgroup analyses, no predetermined end-date
• IPD Sharing Access Criteria: Proposals should be directed to the PI of the study (m.a.h.van.leeuwen@isala.nl). To gain access, data requestors will need to sign a data transfer agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No