Safety and Efficacy of Standardized CHIP

Study Overview
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Brief Summary
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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).

Official Title
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Safety and Efficacy of Standardized Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: percutaneous coronary interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft Exclusion Criteria: Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.) History of recent (within 1 month) stroke or TIA Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHIP 1 - low risk patients<br> | Other: percutaneous coronary interventions<br>* Percutaneous coronary intervention.<br>|
| CHIP 2 - medium risk patients<br> | Other: percutaneous coronary interventions<br>* Percutaneous coronary intervention.<br>|
| CHIP 3 - high risk patients<br> | Other: percutaneous coronary interventions<br>* Percutaneous coronary intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & feasibility | Accurate classification of patients into the respective group defined by the necessity of upgrade | 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 | 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 days |