The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.
This is a multicenter, randomized (2 PiCSO :1 Control), controlled, pilot study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI. Patients with an ST-segment elevated inferior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-V Inferior STEMI study. After consent as per approved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After TIMI flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. The patient is seen for a FU visit at 12-36 hours, 30 days, 6 months and 1 year post index procedure. 12-36 hours and 6 months post index the patient will get a echocardiogram. At every FU visit safety data and health status will be documented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
Aarhus Universitetshospital
Aarhus, Denmark
Odense Universitetshospital
Odense, Denmark
CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque
Bordeaux, France
Adverse Device Effect (ADE) rate at 30 days post index procedure
Adverse Device Effect (ADE) rate at 30 days post index procedure
Time frame: 30 days post MI
A severity index derived as the mean wall motion score within the region of AWM
1\. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Time frame: 12 to 36 hours and 6 months post MI
Ejection fraction using measured by Simpson's method with 2 apical view
1\. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Time frame: 12 to 36 hours and 6 months post MI
The absolute size of the region of abnormal wall motion (AWM)
1\. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Time frame: 12 to 36 hours and 6 months post MI
Percentage of the endocardium involved (%AWM)
1\. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Time frame: 12 to 36 hours and 6 months post MI
Wall motion score
1\. Changes in left and right ventricular function assed by echocardiogram performed within 12 to 36 hours of index PCI and 6 months post index PCI
Time frame: 12 to 36 hours and 6 months post MI
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Centre Hospitalier Régional Universitaire de Lille
Lille, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Pauls Stradins Clinical University Hospital
Riga, Latvia
Bern University Hospital
Bern, Switzerland
EOC Ospedale Regionale di Lugano - Civico
Lugano, Switzerland
Golden Jubilee National Hospital
Clydebank, United Kingdom
New Edinburgh Royal Infirmary
Edinburgh, United Kingdom
...and 1 more locations
hs-Troponin
Maximum and AUC of hs-Troponin
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
C-reactive protein
Maximum, AUC and velocity of C-reactive protein
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
CK-MB
Maximum and AUC of CK-MB
Time frame: hospital admission, 6h, 12h, 24h and then daily until day 5 after PCI or discharge
Blushing index
Blushing index at the end of the procedure
Time frame: Immediately after treatment
ST-segment resolution
ST-segment resolution at 60-90 minutes post flow restoration
Time frame: 60-90 minutes post flow restoration
Device success and procedural success rate presented as % of subjects
Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system
Time frame: 1 day