Symptomatic and increased stroke risk asymptomatic, highly calcific carotid stenoses deemed for endovascular revascularization Circulatory System
Conditions
Interventions
In local aesthesia, after common femoral artery puncture and 9F sheath insertion, a diagnostic catheter is placed in target site common carotid artery, and the target lesion is fully visualized. The d
Sponsors
Jagiellonian University Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of carotid stenosis requiring revascularization: 1.1. Symptomatic stenosis >50% (within 6 months: stroke, transient cerebral ischemia, amaurosis fugax, retinal stroke). 1.2. Asymptomatic stenosis >70-80% with high-risk features (plaque irregularity, thrombus containment, ulceration, containment of large lipid core; evidence of plaque progression) 2. Heavy calcification of carotid stenosis in duplex ultrasound and confirmed in angiography according to HCCS score [Mazurek CCI] 3. Subject deemed medically eligible for intravascular management, per institutional guidelines and clinical judgment 4. Age =18 years, no upper age limit
Exclusion criteria
Exclusion criteria: Lack of the patient agreement for endovascular carotid revascularization or any study related procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined (hierarchical) clinical endpoint of death, stroke, myocardial infarction verified at 30-day Duplex Ultrasound (DUS) outpatient visit or telephone visit by 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Death verified at 30-day DUS outpatient or telephone visit by 30 days 2. Stroke verified at 30-day DUS outpatient or telephone visit by 30 days 3. Myocardial infarction by 30 days according to the 4th universal myocardial infarction definition 4. Combined (hierarchical) clinical endpoint of death, stroke, myocardial infarction, periprocedurally defined as within 48 hours from the procedure or before hospital discharge, whichever comes first 5. Death peri-procedurally measured using the discharge letter from the index hospitalization 6. Stroke peri-procedurally measured using the discharge letter from the index hospitalization 7. Myocardial infarction peri-procedurally (according to the 4th universal myocardial infarction definition) measured using discharge letter from index hospitalization 8. Technical success defined as the effective delivery of IVL, carotid stent and residual stenosis at the time of the index procedure 9. Clinical success defined as technical success without clinical events - no death, stroke, myocardial infarction at from the time of the index procedure until discharge 10. Procedure failure (rate of conversion to open surgery, i.e. number of patients referred to surgery with attempted precutaneous procedure) at the time of scheduled index procedure, surgery may be postponed to a different hospitalization 11. Residual stenosis >30% (assessed by angiography and duplex ultrasound, DUS) at the time of index procedure (angiography), and hospitalization (DUS) 12. Stent thrombosis within 30 days (assessed by DUS, angiography, verified at the 30-day DUS outpatient visit 13. Proportion of patients treated endovascularly (in relation to open surgery) at the time of scheduled index procedure, surgery may be postponed to a different hospitalization 14. Rate of conversion to open surgery (proportion of procedure conversion to open surgery with attempted precutaneous procedure) at the time of the scheduled index procedure, surgery may be postponed to a dif | — |
Countries
Poland
Contacts
Public ContactPiotr Musialek
Outcome results
None listed