atherosclerosis complex coronary lesion
Conditions
Interventions
Ultrasound guided femoral access versus fluoroscopy guided femoral access.
Sponsors
Maatschap Cardiologie Isala Zwolle
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Use of the femoral artery for primary or secondary access with >= 7 Fr guiding catheter as indication for complex PCI, according to the expertise of the treating physician. 2) Age 18 years or older.
Exclusion criteria
Exclusion criteria: 1) Inability to obtain informed consent 2) Contra-indication for femoral access 3) Cardiogenic shock 4) ST elevation myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate if ultrasound guided primary femoral access is associated with less clinically relevant access site related bleeding (BARC 2,3 or 5) and/or vascular complication requiring intervention as compared to fluoroscopy guided cannulation for complex PCI with large-bore access. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare ultrasound guided with fluoroscopy guided femoral access for complex PCI with large-bore access with regard to the following objectives (definitions in appendix I): - BARC 2, 3 or 5 access-site related bleeding or vascular complication of secondary access site (femoral or radial, defined in appendix I) - MACE - Procedural duration - First pass puncture - Accidental venous puncture - Vascular complication not requiring intervention - Vascular closure device failure | — |
Countries
Netherlands
Outcome results
None listed