Status:
COMPLETED
PiCSO in ACS Study
Lead Sponsor:
Miracor Medical SA
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
25-75 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
- Culprit lesion in the LAD.
- Age range 25 - 75 years
Exclusion
- 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).
- Previous coronary artery bypass graft surgery
- History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
- Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
- Active or treated malignancies in the last 12 months
- Pregnant Women
- Non-cardiac comorbidities and life expectancy \< 1 year
- Use of warfarin
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT02197325
Start Date
January 1 2015
End Date
November 1 2017
Last Update
March 18 2019
Active Locations (4)
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1
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
2
St Bartholomew's Hospital
London, United Kingdom
3
Freeman Hospital
Newcastle, United Kingdom
4
Northern General Hospital
Sheffield, United Kingdom