I25.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Manifest coronary artery disease confirmed by CT coronary angiography with an indication for invasive coronary angiography - CT coronary angiography and invasive coronary angiography performed at GRN Clinic Weinheim - Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: - Patients in whom, despite a positive CT angiography, no need for intervention is identified by invasive angiography or by coronary physiological assessment (iFR/RFR/FFR) - Lack of informed consent from the participants - Pregnant women, age < 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Need to change the guiding catheter - Need for lesion pre-treatment using rotational atherectomy or intravascular lithotripsy - Need for intravascular imaging using intravascular ultrasound (IVUS) - Length of the anticipated diseased vessel segments; number, diameter, and length of implanted stents - Occurrence of procedural complications (perforation, severe dissection, stent malapposition or underexpansion requiring post-dilatation, transient or permanent occlusion of the main vessel or side branch) - Troponin T increase (pre- vs. post-interventional) - Procedure duration, cumulative radiation exposure, and contrast agent volume - Length of hospital stay (days) - Composite endpoint (score 0–6): - Need for IVUS - Occurrence of at least one of the procedural complications listed above - Troponin T increase on the following day (>5-fold from baseline) - Contrast agent volume >200 mL - Radiation exposure >3 mSv - Hospital stay >1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cardiac death, stent thrombosis, myocardial infarction, in-stent restenosis, and target lesion revascularization. All of the above events are assessed at 6, 12, and 24 months after the index procedure. - Standardized quality-of-life questionnaire (SAQ [Seattle Angina Questionnaire]-7 score) at 6, 12, and 24 months - Material consumption, material costs, and total treatment costs | — |
Countries
Germany
Contacts
GRN Klinik Weinheim