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First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI patients | Experimental | Adult subjects presenting with STEMI in the LAD undergoing PPCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorFlow Controlled Flow Infusion System - CoFI™ | Device | The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of study device or study procedure adverse effect or event | Safety Objective is the incidence of study device or study procedure adverse effect or event at up to 30 days. To assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Success | Ability to perform a diagnostic sequence and to calculate a base flow resistance curve | 0 days |
| Therapeutic Success | Ability to perform the therapeutic sequence as described in the CIP |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Hunziker | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos | Kaunas | 50161 | Lithuania | |||
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N= 50 Diagnostic and N= 20 Therapeutic
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| 0 days |
| Vilnius University Hospital Santariskiu Klinikos |
| Vilnius |
| 08661 |
| Lithuania |
| Inselspital Bern | Bern | Canton of Bern | Switzerland |
| Cardiocentro Ticino | Lugano | Canton Ticino | 6900 | Switzerland |
| HUG Geneva | Geneva | Switzerland |
| CHUV Lausanne | Lausanne | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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