Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565039
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The SUPPORT CE Study A Safety and Effectiveness Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention HRPCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPORT CE
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI
Detailed Description:
The Supira System is a temporary 4 hours ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team including a cardiac surgeon has determined HRPCI is the appropriate therapeutic option
Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events
Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None