Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02197325
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2014-07-16
Brief Title:
PiCSO in ACS Study
Sponsor:
Miracor Medical SA
Organization:
Miracor Medical SA
Study Overview
Official Title:
Pressure Controlled Intermittent Coronary Sinus Occlusion PiCSO as an Adjunct to PCI in Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out whether PICSO Pressure Controlled Coronary Sinus Occlusion given concomitant to NSTEMI or following STEMI primary PCI and stenting can improve final infarct size and myocardial function
ACS patients NSTEMI and STEMI with a culprit lesion in the LAD will be treated according to standard treatment PCI followed by stent placement with or without PICSO therapy In NSTEMI patients PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion PICSO therapy is initiated prior to stent deployment and continued during stenting The functional efficacy measures related to the PICSO duration and coronary sinus pressures will be stored on the PICSO Impulse console and analysed offline The clinical efficacy measures cardiac enzyme release during 24 hour following PCI cardiac function infarct size and level of microvascular obstruction will be assessed by cMRI Patients will be followed for a maximum of 4 months after the primary PCI procedure
ACS patients NSTEMI and STEMI with a culprit lesion in the LAD will be treated according to standard treatment PCI followed by stent placement with or without PICSO therapy In NSTEMI patients PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion PICSO therapy is initiated prior to stent deployment and continued during stenting The functional efficacy measures related to the PICSO duration and coronary sinus pressures will be stored on the PICSO Impulse console and analysed offline The clinical efficacy measures cardiac enzyme release during 24 hour following PCI cardiac function infarct size and level of microvascular obstruction will be assessed by cMRI Patients will be followed for a maximum of 4 months after the primary PCI procedure
Detailed Description:
The study is designed to evaluate the effect of PICSO treatment concomitant to or following primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or ST-segment Elevation Myocardial Infarction in patients with a culprit lesion in the LAD on Infarct Size and myocardial function There will be 2 phases in this study
1 Phase 1 only NSTEMI patients will be recruited
2 Phase 2 only STEMI patients will be recruited
Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited After having given informed consent the patient will be scheduled for pPCI and stent placement On the day of the procedure the PICSO catheter will be placed as described below refer to PICSO Impulse catheter placement After the PICSO therapy is started the standard pPCI and stent placement is performed PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes
Phase 2 During Phase 2 of the study only STEMI patients will be recruited Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below Refer to PICSO Impulse catheter placement
After correct positioning of the PICSO Impulse catheter the 0032 guide wire is removed PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first With PICSO in treatment mode the stent is deployed
The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI Examinations include but are not limited to physical assessments cardiac markers ECG laboratory results x-rays angiograms cMRI and echocardiography
1 Phase 1 only NSTEMI patients will be recruited
2 Phase 2 only STEMI patients will be recruited
Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited After having given informed consent the patient will be scheduled for pPCI and stent placement On the day of the procedure the PICSO catheter will be placed as described below refer to PICSO Impulse catheter placement After the PICSO therapy is started the standard pPCI and stent placement is performed PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes
Phase 2 During Phase 2 of the study only STEMI patients will be recruited Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below Refer to PICSO Impulse catheter placement
After correct positioning of the PICSO Impulse catheter the 0032 guide wire is removed PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first With PICSO in treatment mode the stent is deployed
The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI Examinations include but are not limited to physical assessments cardiac markers ECG laboratory results x-rays angiograms cMRI and echocardiography
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