In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients. The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).
Study Type
OBSERVATIONAL
Enrollment
150
Percutaneous coronary intervention.
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Safety & feasibility
Accurate classification of patients into the respective group defined by the necessity of upgrade
Time frame: 30 days
Hemodynamic Compromise (HC)
Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure
Time frame: 30 days.
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
A composite rate of the following intra-procedural and post-procedural Major Adverse Cardiac and Cerebrovascular Events (MACCE) events defined as death, new myocardial infarction, or cerebrovascular accident up to 30 days post index procedure.
Time frame: 30 days
Adverse events
Rates of acute kidney injury (\[AKI\] according to KDIGO), sepsis, vascular complications (defined by Valve Academic Research Consortium 2 \[VARC 2\]), bleeding (defined by Bleeding Academic Research Consortium \[BARC\]) and coronary complications.
Time frame: 30 days
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