Complex Coronary LesionsColorNCT03846752
Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial
A study testing radial artery access for complex PCI and femoral artery access for complex PCI in people with Complex Coronary Lesions, run by Maatschap Cardiologie Zwolle at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Coronary Lesions
- What is being tested?
- radial artery access for complex PCI and femoral artery access for complex PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 5 Mar 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician.
- Age 18 years or older.
Who cannot join
- Inability to obtain informed consent
- contra-indication for radial or femoral access
- Cardiogenic shock
- ST-elevation myocardial infarction
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Netherlands6 sites
Noordwest Ziekenhuisgroep
Alkmaar
OLVG
Amsterdam
VUMC
Amsterdam
Catharina Ziekenhuis Eindhoven
Eindhoven
RadboudUMC
Nijmegen
Isala
Zwolle, Overijssel
Belgium3 sites
ZNA Middelheim
Antwerp
CHU Charleroi
Charleroi
Ziekenhuis Oost Limburg
Genk
United Kingdom1 site
Frimley Health NHS Foundation Trust, Surrey
Camberley
About this study
Official title: 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.
Read the 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.
- Conditions
- Complex Coronary Lesions
- Being tested
- radial artery access for complex PCI, femoral artery access for complex PCI
- Keywords
- Transradial Intervention, transfemoral intervention, PCI for complex coronary lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial artery access for complex PCIProcedure or surgery
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.
femoral artery access for complex PCIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 7 Fr. radial access | Active comparator | radial artery access for complex PCI Receives: Procedure: radial artery access for complex PCI |
| 7 Fr. femoral access | Active comparator | femoral artery access for complex PCI Receives: Procedure: femoral artery access for complex PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization)
Measured: 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
Measured: PCI procedure till 30 days after PCI procedure
Procedural success
Successful PCI of the target lesion with a residual stenosis of less than 20%
Measured: during PCI procedure
procedural time
Procedural time from puncture to end procedure (in minutes)
Measured: during PCI procedure
fluoroscopy time
fluoroscopy time (in seconds)
Measured: during PCI procedure
contrast use
Contrast volume used (in ml)
Measured: 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
Measured: during PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start5 Mar 2019
- Primary completion22 Apr 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complex Coronary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maatschap Cardiologie Zwolle
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Europe N.V.
- Responsible party
- Sponsor
- Investigators
- Maarten A. Van Leeuwen, MD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846752
- Sponsor's protocol ID
- 9285
- Other IDs
- NL66831.075.18, 180716
- Acronym
- Color
- Status last verified
- Aug 2020
- First submitted
- 14 Feb 2019
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36456007Meijers 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.
PubMed 35023343Meijers 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.
PubMed 34020929Meijers 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.
PubMed 32690749
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI
- ClinicalTrials.gov ID
- NCT03846752
- Acronym / sponsor ID
- Color / 9285
- Conditions
- Complex Coronary Lesions
- Keywords
- Transradial Intervention, transfemoral intervention, PCI for complex coronary lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Maatschap Cardiologie ZwolleUniversity, hospital or other
- Collaborators
- Terumo Europe N.V.
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 Fr. radial access | Active comparator | Procedure: radial artery access for complex PCIradial artery access for complex PCI |
| 7 Fr. femoral access | Active comparator | Procedure: femoral artery access for complex PCIfemoral artery access for complex PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Use of 7 Fr guiding catheter is indicated for complex PCI, according to the expertise of the treating physician.
- Age 18 years or older.
Key exclusion criteria (4 listed)
- Inability to obtain informed consent
- contra-indication for radial or femoral access
- Cardiogenic shock
- ST-elevation myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radial artery access for complex PCIComplex 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. | Procedure or surgery | 7 Fr. radial access |
| femoral artery access for complex PCIComplex 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. | Procedure or surgery | 7 Fr. femoral access |
Primary outcome
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).
7 secondary outcomes
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
MACE (hospitalization and 1-month)
Time frame: PCI procedure till 30 days after PCI procedure
Procedural success
Time frame: during PCI procedure
procedural time
Time frame: during PCI procedure
fluoroscopy time
Time frame: during PCI procedure
contrast use
Time frame: during PCI procedure
crossover rate
Time frame: during PCI procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 36456007Meijers 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.
- Derived from this study: PubMed 35023343Meijers 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.
- Derived from this study: PubMed 34020929Meijers 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.
- Derived from this study: PubMed 32690749Meijers 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten A. Van Leeuwen, MD principal investigator
Isala
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial artery access for complex PCI and femoral artery access for complex PCI in people with Complex Coronary Lesions, run by Maatschap Cardiologie Zwolle at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, Belgium, Germany, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846752, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.