PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

Not Applicable

Completed

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

• Registration Number: NCT01493037
• Lead Sponsor: Miracor Medical SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Primary Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PICSO	PICSO (Pressure-controlled Intermittent Coronary Occlusion	PICSO treatment for 90 minutes

Primary Outcome Measures

Name	Time	Method
Successful delivery of PICSO treatment	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

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

Trial Locations

Locations (2)

Academic Medical Center - University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Amphia Hospital; 🇳🇱 Breda, Netherlands