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

• ClinicalTrials.gov Identifier: NCT03846752
• Recruitment Status: Completed
• First Posted: February 20, 2019
• Last Update Posted: August 18, 2020
• Sponsor: Maatschap Cardiologie Zwolle
• Collaborator: Terumo Europe N.V.
• Information provided by (Responsible Party): Maatschap Cardiologie Zwolle

Study Description

Brief 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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 388 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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)
2. MACE (hospitalization and 1-month) [ Time Frame: PCI procedure till 30 days after PCI procedure ]
   MACE: Composite of death, myocardial infarction and repeat revascularization
3. Procedural success [ Time Frame: during PCI procedure ]
   Successful PCI of the target lesion with a residual stenosis of less than 20%
4. procedural time [ Time Frame: during PCI procedure ]
   Procedural time from puncture to end procedure (in minutes)
5. fluoroscopy time [ Time Frame: during PCI procedure ]
   fluoroscopy time (in seconds)
6. contrast use [ Time Frame: during PCI procedure ]
   Contrast volume used (in ml)
7. 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Belgium

ZNA Middelheim

Antwerpen, Belgium

CHU Charleroi

Charleroi, Belgium

Ziekenhuis Oost Limburg

Genk, Belgium

Germany

Elisabeth Krankenhaus

Essen, Germany

Netherlands

Isala

Zwolle, Overijssel, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

OLVG

Amsterdam, Netherlands

VUMC

Amsterdam, Netherlands

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

RadboudUMC

Nijmegen, Netherlands

Switzerland

University Hospital Geneva

Geneva, Switzerland

United Kingdom

Frimley Health NHS Foundation Trust, Surrey

Camberley, United Kingdom

Sponsors and Collaborators

Maatschap Cardiologie Zwolle

Terumo Europe N.V.

Investigators

• Principal Investigator: Maarten A. Van Leeuwen, MD; Isala

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maatschap Cardiologie Zwolle
• ClinicalTrials.gov Identifier: NCT03846752
• Other Study ID Numbers: 9285; NL66831.075.18 ( Registry Identifier: CCMO ); 180716 ( Other Identifier: Dutch ethical committe )
• First Posted: February 20, 2019
• Last Update Posted: August 18, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data is available after publication of final specific subgroup analyses, no predetermined end-date
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maatschap Cardiologie Zwolle:

Transradial Intervention; transfemoral intervention; PCI for complex coronary lesions