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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miracor Medical Systems
ClinicalTrials.gov Identifier:
NCT01493037
First received: December 13, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention
ST Elevation (STEMI) Myocardial Infarction
Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Miracor Medical Systems:

Primary Outcome Measures:
  • Successful delivery of PICSO treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]
    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:
  • MRI measurement of infarct size [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up

  • Assessment of left ventricular function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days

  • Assessment of microvascular perfusion [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days

  • Resolution of ST-segment elevation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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

  • Measurement of ST segment time curve area [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.

  • Number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 30
Study Start Date: December 2011
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493037

Locations
Netherlands
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Amphia Hospital
Breda, Netherlands
Sponsors and Collaborators
Miracor Medical Systems
Investigators
Principal Investigator: Jan J Piek, Professor Academic Medical Center University of Amsterdam
  More Information

No publications provided

Responsible Party: Miracor Medical Systems
ClinicalTrials.gov Identifier: NCT01493037     History of Changes
Other Study ID Numbers: CIP 2011-01
Study First Received: December 13, 2011
Last Updated: July 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Miracor Medical Systems:
STEMI
PICSO
Coronary Sinus
Involving Left Anterior Descending Coronary Artery

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014