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Remote Ischemic Conditioning Using the autoRIC

NCT03318575 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2018-08-31

No results posted yet for this study

Summary

The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).

Conditions

  • Ischemia-Reperfusion Injury

Interventions

DEVICE

autoRIC

Automated Remote Ischemic Conditioning

DEVICE

autoRIC Sham

Automated Remote Ischemic Conditioning Sham

Sponsors & Collaborators

  • CellAegis US, Inc.

    lead INDUSTRY

Principal Investigators

  • Roxana Mehran, MD · Cardiovascular Medicine Associates

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Device
Yes

Countries

  • United States
  • Canada

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 NCT03318575 on ClinicalTrials.gov