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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHIP 1 - low risk patients |
| ||
| CHIP 2 - medium risk patients |
| ||
| CHIP 3 - high risk patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous coronary interventions | Other | Percutaneous coronary intervention. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |