Complex Coronary Lesions
Conditions
Keywords
Transradial Intervention, transfemoral intervention, PCI for complex coronary lesions
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.
Interventions
PROCEDUREradial 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.
PROCEDUREfemoral 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.
Sponsors
Terumo Europe N.V.
Maatschap Cardiologie Zwolle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| MACE (hospitalization and 1-month) | PCI procedure till 30 days after PCI procedure | MACE: Composite of death, myocardial infarction and repeat revascularization |
| Procedural success | during PCI procedure | Successful PCI of the target lesion with a residual stenosis of less than 20% |
| procedural time | during PCI procedure | Procedural time from puncture to end procedure (in minutes) |
| 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 | Non-access site related BARC 2,3 and 5 bleeding and/or vascular complications (hospitalization) |
| contrast use | during PCI procedure | Contrast volume used (in ml) |
| crossover rate | 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 |
| fluoroscopy time | during PCI procedure | fluoroscopy time (in seconds) |
Countries
Belgium, Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed