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A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients

NCT05497011 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-24

No results posted yet for this study

Summary

The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).

Conditions

  • STEMI - ST Elevation Myocardial Infarction
  • Anterior Wall Myocardial Infarction

Interventions

DEVICE

PiCSO Impulse System

After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.

Sponsors & Collaborators

  • Miracor Medical SA

    lead INDUSTRY

Principal Investigators

  • Gregg W. Stone, Prof. · Mount Sinai, New York, US

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2025-07-31
Completion
2028-06-30
FDA Device
Yes

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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 NCT05497011 on ClinicalTrials.gov