MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction (e-MASTER)

August 31, 2015 updated by: InspireMD

e-MASTER Registry: MGuard™ Prime Embolic Protection Stent in Patients With Acute ST Elevation Myocardial Infarction

Prospective, non-randomized, single arm, multicenter observational study. The objective is to evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction (STEMI) in a real-world setting.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing primary revascularization for STEMI and who are intended to undergo primary PCI with the MGuard™ Prime Embolic Protection Stent System.

Description

Inclusion Criteria:

  1. Subject is >18 years of age.
  2. Subject is experiencing clinical symptoms consistent with ST elevation acute myocardial infarction (STEMI) of >30 minutes and <24 hours.
  3. Based on coronary anatomy, primary PCI is indicated for the culprit lesion with anticipated use of stenting.
  4. Subject agrees to all required follow-up procedures and visits and has provided informed consent where required.
  5. The target lesion is a de novo lesion in a native coronary artery.
  6. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment.

Exclusion Criteria:

  1. Subject undergoing cardiopulmonary resuscitation.
  2. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
  3. Co-morbid condition(s) or others that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
  4. Target lesion involves a bifurcation with a side branch >/=2.0 mm in diameter.
  5. In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the MGuard™ Prime Embolic Protection Stent System for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete ST-segment resolution
Time Frame: 1 day
1 day
All cause death or MI at 30 days
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
TIMI flow grade
Time Frame: 1 day
1 day
Major Adverse Cardiac Events rate (MACE): cardiac death, re-MI, clinically-driven target lesion revascularization (TLR)
Time Frame: Discharge, 30 days, 6 months, 12 months
Discharge, 30 days, 6 months, 12 months
Acute success rates
Time Frame: 1 day
1 day
Stent thrombosis rate
Time Frame: Discharge, 30 days, 6 months,12 months
Discharge, 30 days, 6 months,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InspireMD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMD-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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