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PICSO in Patients With STEMI Treated by Primary Percutaneous Coronary Intervention

NCT01493037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-07-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Miracor Medical SA

    lead INDUSTRY

Principal Investigators

  • Jan J Piek, Professor · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493037 on ClinicalTrials.gov