Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criteria

Culprit lesion in the LAD.
Age range 25 - 75 years
Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
Culprit lesion in the LAD.
Age range 25 - 75 years
Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)

Exclusion Criteria

Previous coronary artery bypass graft surgery
Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
Pregnant Women
...
Previous coronary artery bypass graft surgery
Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
Pregnant Women
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).
Active or treated malignancies in the last 12 months
Non-cardiac comorbidities and life expectancy < 1 year
Use of warfarin
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

Summary

Conditions
Acute Coronary Syndrome
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 25 years and 75 years
Gender
Both males and females

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 ...

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. Phase 1: only NSTEMI patients will be recruited. 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 0,032" 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.

Inclusion Criteria

Culprit lesion in the LAD.
Age range 25 - 75 years
Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
Culprit lesion in the LAD.
Age range 25 - 75 years
Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)

Exclusion Criteria

Previous coronary artery bypass graft surgery
Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
Pregnant Women
...
Previous coronary artery bypass graft surgery
Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
Pregnant Women
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).
Active or treated malignancies in the last 12 months
Non-cardiac comorbidities and life expectancy < 1 year
Use of warfarin
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

Tracking Information

NCT #
NCT02197325
Collaborators
Not Provided
Investigators
  • Principal Investigator: Azfar Zaman, Prof. Dr. Freeman Hospital Newcastle
  • Azfar Zaman, Prof. Dr. Freeman Hospital Newcastle
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