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MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

NCT01869738 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2015-09-02

No results posted yet for this study

Summary

To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DEVICE

MGuard Prime

DEVICE

(BMS/DES)

Sponsors & Collaborators

  • InspireMD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Belgium
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Spain
  • 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 NCT01869738 on ClinicalTrials.gov