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| ID | Type | Description | Link |
|---|---|---|---|
| NL66831.075.18 | Registry Identifier | CCMO | |
| 180716 | Other Identifier | Dutch ethical committe |
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| Name | Class |
|---|---|
| Terumo Europe N.V. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 Fr. radial access | Active Comparator | radial artery access for complex PCI |
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| 7 Fr. femoral access | Active Comparator | femoral artery access for complex PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radial artery access for complex PCI | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten A. Van Leeuwen, MD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Middelheim | Antwerp | Belgium | ||||
| CHU Charleroi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36456007 | Derived | 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. | |
| 35023343 |
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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.
Data is available after publication of final specific subgroup analyses, no predetermined end-date
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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|
| femoral artery access for complex PCI | Procedure | 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. |
|
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 |
| Charleroi |
| Belgium |
| Ziekenhuis Oost Limburg | Genk | Belgium |
| Elisabeth Krankenhaus | Essen | Germany |
| Isala | Zwolle | Overijssel | Netherlands |
| Noordwest Ziekenhuisgroep | Alkmaar | Netherlands |
| OLVG | Amsterdam | Netherlands |
| VUMC | Amsterdam | Netherlands |
| Catharina Ziekenhuis Eindhoven | Eindhoven | Netherlands |
| RadboudUMC | Nijmegen | Netherlands |
| University Hospital Geneva | Geneva | Switzerland |
| Frimley Health NHS Foundation Trust, Surrey | Camberley | United Kingdom |
| 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. |
| 34020929 | Derived | 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. |
| 32690749 | Derived | 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. |