MedTrace Logo

OCT Study of the MGuard Prime Stent in Patients With Heart Attacks

NCT02222116 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-03-31

No results posted yet for this study

Summary

The objective is to demonstrate that the Flow Area within a blocked coronary vessel as assessed by OCT is greater with the MGuard Prime stent compared to non-mesh control stent (BMS/DES) in subjects undergoing primary PCI for ST-segment elevation MI. The study hypothesis is that end of procedure flow area is greater with the MGuard Prime compared with stenting with a non-mesh DES or BMS.

Conditions

  • ST Segment Elevated Myocardial Infarction

Interventions

DEVICE

MGuard Prime

DEVICE

Control BMS DES

Sponsors & Collaborators

  • InspireMD

    lead INDUSTRY

Principal Investigators

  • Ori Ben Yehuda, MD · CRF

  • Simon Eccleshall, MD · Norfolk and Norwhich Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • United Kingdom

More Related Trials

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 NCT02222116 on ClinicalTrials.gov