Clinical trial NCT03846752: Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial
Official title: Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Coronary Lesions
Keywords: Transradial Intervention
transfemoral intervention
PCI for complex coronary lesions
Lead sponsor: Maatschap Cardiologie Zwolle
Sponsor class: OTHER
Collaborators: name: Terumo Europe N.V.
First posted: 2019-02-20
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
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).
timeFrame: PCI procedure till patients is discharged from the hospital, with a maximum of 30 days
Secondary outcomes:
measure: Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization)
timeFrame: PCI procedure till patients is discharged from the hospital, with a maximum of 30 days
measure: MACE (hospitalization and 1-month)
timeFrame: PCI procedure till 30 days after PCI procedure
measure: Procedural success
timeFrame: during PCI procedure
measure: procedural time
timeFrame: during PCI procedure
measure: fluoroscopy time
timeFrame: during PCI procedure
measure: contrast use
timeFrame: during PCI procedure
measure: crossover rate
timeFrame: during PCI procedure
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: VUMC
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Nijmegen
country: Netherlands
facility: RadboudUMC
city: Geneva
country: Switzerland
facility: University Hospital Geneva
city: Camberley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust, Surrey
Study officials:
affiliation: Isala
name: Maarten A. Van Leeuwen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.