NCT03846752

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

February 14, 2019

Last Update Submit

August 17, 2020

Conditions

Complex Coronary Lesions

Keywords

Transradial Interventiontransfemoral interventionPCI for complex coronary lesions

Outcome Measures

Primary Outcomes (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).

    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 Outcomes (7)

  • 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)

    PCI procedure till 30 days after PCI procedure

  • Procedural success

    during PCI procedure

  • procedural time

    during PCI procedure

  • fluoroscopy time

    during PCI procedure

  • +2 more secondary outcomes

Study Arms (2)

7 Fr. radial access

ACTIVE COMPARATOR

radial artery access for complex PCI

Procedure: radial artery access for complex PCI

7 Fr. femoral access

ACTIVE COMPARATOR

femoral artery access for complex PCI

Procedure: femoral artery access for complex PCI

Interventions

radial artery access for complex PCIPROCEDURE

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.

7 Fr. radial access
femoral artery access for complex PCIPROCEDURE

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.

7 Fr. femoral access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician.
  • Age 18 years or older.

You may not qualify if:

  • Inability to obtain informed consent
  • contra-indication for radial or femoral access
  • Cardiogenic shock
  • ST-elevation myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

ZNA Middelheim

Antwerp, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

Ziekenhuis Oost Limburg

Genk, Belgium

Location

Elisabeth Krankenhaus

Essen, Germany

Location

Isala

Zwolle, Overijssel, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

VUMC

Amsterdam, Netherlands

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Location

RadboudUMC

Nijmegen, Netherlands

Location

University Hospital Geneva

Geneva, Switzerland

Location

Frimley Health NHS Foundation Trust, Surrey

Camberley, United Kingdom

Location

Related Publications (4)

  • Meijers TA, Nap A, Aminian A, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Schmitz T, Bataille Y, Kraaijeveld AO, Roolvink V, Hermanides RS, Braber TL, van Royen N, van Leeuwen MAH. ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial. BMJ Open. 2022 Dec 1;12(12):e065693. doi: 10.1136/bmjopen-2022-065693.

    PMID: 36456007DERIVED

  • 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.

    PMID: 35023343DERIVED

  • 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.

    PMID: 34020929DERIVED

  • 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.

    PMID: 32690749DERIVED

Study Officials

  • Maarten A. Van Leeuwen, MD

    Isala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 20, 2019

Study Start

March 5, 2019

Primary Completion

April 22, 2020

Study Completion

May 20, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations

DE(1)NL(6)GB(1)BE(3)CH(1)