Anterior MI, STEMI
Conditions
Keywords
PiCSO, PiCSO Impulse System
Brief summary
The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).
Detailed description
This is a prospective, multicenter, randomized (1:1), controlled, study. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-I study. After consent as per pproved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial 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 (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. 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 5 days, 30 days, 6 months, 1 year, 2 year and 3 years post index procedure. 5 days and 6 months post index the patient will get a CMR scan. At every FU visit safety data and health status will be documented and quality of life questionnaire will be completed.
Interventions
DEVICEPiCSO
After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial 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 (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
Sponsors
Miracor Medical SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Analysis of the primary endpoint, infarct size 5-days post MI assessed by CMR, will be analyzed by an independent Corelab, blinded to the allocated treatment arm.
Intervention model description
A prospective, multicenter, randomized (1:1), controlled, study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Culprit lesion in proximal or mid LAD 3. Pre-PCI TIMI flow 0 or 1. 4. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h. 5. ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women 6. Patient is deemed eligible for primary PCI 7. STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.
Exclusion criteria
1. Implants or foreign bodies in the coronary sinus 2. Known allergy to polyurethanes, PET or stainless steel 3. Known pregnancy and breastfeeding 4. Pericardial effusion (cardiac tamponade) 5. Central hemodynamically relevant left/right shunt 6. Previous MI or CABG 7. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months 8. Known coagulopathy 9. Need for circulatory support or pre-procedural ventilation 10. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 minutes 11. Patient not suitable for femoral vein access 12. Contraindication to cardiac magnetic resonance imaging (CMR), e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance. 13. Active participation in another drug or device investigational study 14. Known severe kidney disease or on hemodialysis 15. Unconscious on presentation 16. Patients under judicial protection, legal guardianship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size 5 days post MI | 5 days post MI | Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of LV mass) between the PiCSO Group and the Control Group, assessed by CMR at 5 days post index PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MVO | 5 days post MI | Occurrence and extent of microvascular obstruction (MVO, % of LV mass) and hemorrhage assessed by CMR at 5 days post index PCI |
| LVEF | 5 days and 6 months post MI | LVEF assessed by CMR at 5 days and 6 months post index PCI |
| LVESV | 5 days and 6 months post MI | LVESV assessed by CMR at 5 days and 6 months post index PCI |
| Infarct size 6 months post MI | 6 months post MI | Myocardial infarct size (% of LV mass) assessed by CMR at 6 months post index PCI |
| Myocardial Salvage | 5 days and 6 months post MI | Myocardial Salvage Index at 5 days and 6 month post index PCI |
| ST-segment resolution | 90 minutes | ST-segment resolution at 90 minutes post flow restoration |
| Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system | 1 day | Device success and procedural success rate presented as % of subjects |
| LVEDV | 5 days and 6 months post MI | LVEDV assessed by CMR at 5 days and 6 months post index PCI |
Countries
Denmark, France, Germany, Latvia, Switzerland, United Kingdom
Outcome results
None listed