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Trial record 1 of 1 for:    COLOR trial complex percutaneous coronary intervention
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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
Sponsor:
Collaborator:
Terumo Europe N.V.
Information provided by (Responsible Party):
Maatschap Cardiologie Zwolle

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.

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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

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Maarten A. Van Leeuwen, MD Isala
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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.

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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