PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

NCT ID: NCT01493037

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

ST Elevation (STEMI) Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PICSO

PICSO treatment for 90 minutes

Group Type: OTHER

PICSO (Pressure-controlled Intermittent Coronary Occlusion

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

PICSO Impulse Catheter; PICSO Impulse Console

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miracor Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan J Piek, Professor

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Academic Medical Center - University of Amsterdam

Amsterdam, , Netherlands

Amphia Hospital

Breda, , Netherlands

Countries

Netherlands

Other Identifiers

CIP 2011-01

Identifier Type: -

Identifier Source: org_study_id