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PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention (pRAMSES)

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ClinicalTrials.gov Identifier: NCT01493037
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Miracor Medical SA

Study Description
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Brief Summary:
A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.

Condition or disease Intervention/treatment Phase
ST Elevation (STEMI) Myocardial Infarction Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study
Study Start Date : December 2011
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
PICSO
PICSO treatment for 90 minutes
 Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion
The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.
Other Names:
  • PICSO Impulse Catheter
  • PICSO Impulse Console


Outcome Measures
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Primary Outcome Measures :
  1. Successful delivery of PICSO treatment [ Time Frame: 90 minutes ]
    Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes


Secondary Outcome Measures :
  1. MRI measurement of infarct size [ Time Frame: 4 months ]
    Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up

  2. Assessment of left ventricular function [ Time Frame: 4 months ]
    Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days

  3. Assessment of microvascular perfusion [ Time Frame: 4 months ]
    Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days

  4. Resolution of ST-segment elevation [ Time Frame: 24 hours ]
    Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12 lead ECG Holter monitor recording

  5. Measurement of ST segment time curve area [ Time Frame: 3 hours ]
    ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.

  6. Number of adverse events [ Time Frame: 6 months ]
    Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First time anterior STEMI defined by the following:

    • Symptoms of myocardial ischemia > 30 minutes and < 12 hours
    • ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
  • Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)

Exclusion Criteria:

  • Younger than 18 years of age
  • Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
  • Left main coronary artery culprit lesion
  • Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
  • Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
  • Cardiac arrest requiring chest compression or resuscitation
  • Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
  • Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
  • History of stroke, TIA or reversible ischemic neurological disease within last 6 months
  • Left bundle branch block
  • Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
  • Presence of any lead in the coronary sinus
  • Active or treated malignancies in the last 12 months
  • Previous coronary artery bypass graft surgery
  • Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
  • Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
  • Participation in another ongoing clinical study
  • Women of child-bearing age
  • Non-cardiac comorbidities and life expectancy < 1 year
  • Legal incompetence
  • A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
  • No dependents neither to the sponsor nor to the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493037


Locations
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Netherlands
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Amphia Hospital
Breda, Netherlands
Sponsors and Collaborators
Miracor Medical SA
Investigators
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Principal Investigator: Jan J Piek, Professor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: Miracor Medical SA
ClinicalTrials.gov Identifier: NCT01493037    
Other Study ID Numbers: CIP 2011-01
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Miracor Medical SA:
STEMI
PICSO
Coronary Sinus
Involving Left Anterior Descending Coronary Artery
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases