PiCSO in ACS Study

Launched by MIRACOR MEDICAL SA · Jul 18, 2014

Keywords

ClinConnect Summary

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 fo...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
• • 2. Culprit lesion in the LAD.
• • 3. Age range 25 - 75 years
• Exclusion Criteria:
• • 1. Complicated PCI of an LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting with the occurrence of an adverse event(s) that would preclude further interventional procedures during the index procedure, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgment of the investigator precludes use of the PICSO Impulse System).
• • 2. Previous coronary artery bypass graft surgery
• • 3. History of stroke, TIA or reversible ischemic neurological disease within last 6 months
• • 4. Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
• • 5. Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
• • 6. Active or treated malignancies in the last 12 months
• • 7. Pregnant Women
• • 8. Non-cardiac comorbidities and life expectancy \< 1 year
• • 9. Use of warfarin