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

Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: ST Elevation (STEMI) Myocardial Infarction
• Intervention / Treatment: Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center - University of Amsterdam
  • Breda, Netherlands
    • Amphia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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 Console; PICSO Impulse Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful delivery of PICSO treatment	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	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI measurement of infarct size	Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up	4 months
Assessment of left ventricular function	Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days	4 months
Assessment of microvascular perfusion	Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days	4 months
Resolution of ST-segment elevation	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	24 hours
Measurement of ST segment time curve area	ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.	3 hours
Number of adverse events	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	6 months

Collaborators and Investigators

• Sponsor: Miracor Medical SA
• Investigators: Principal Investigator: Jan J Piek, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (ESTIMATE): December 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: STEMI; Coronary Sinus; PICSO; Involving Left Anterior Descending Coronary Artery
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CIP 2011-01