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PiCSO in ACS Study

NCT02197325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-03-18

No results posted yet for this study

Summary

The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and stenting, can improve final infarct size and myocardial function.

ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and continued during stenting. The functional efficacy measures, related to the PICSO duration and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI, cardiac function, infarct size and level of microvascular obstruction will be assessed by cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure

Conditions

  • Acute Coronary Syndrome

Interventions

DEVICE

PICSO

Pressure controlled Intermittent Coronary Pressure Occlusion

Sponsors & Collaborators

  • Miracor Medical SA

    lead INDUSTRY

Principal Investigators

  • Azfar Zaman, Prof. Dr. · Freeman Hospital, Newcastle

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

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 NCT02197325 on ClinicalTrials.gov