OCT Study of the MGuard Prime Stent in Patients With Heart Attacks (MASTER-OCT)

March 29, 2015 updated by: InspireMD

OCT Study of the MGuard Prime Embolic Protection Stent in Patients With Acute ST-segment Elevation Myocardial Infarction

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

  • United Kingdom
      • Norfolk, United Kingdom
        • Norfolk and Norwhich Hospital

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

Description

Inclusion Criteria:

  • Subject is >18 years of age.
  • Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and ≤12 hours in duration.
  • ST-segment elevation ≥1 mm per lead in ≥2 contiguous leads is present in at least one ECG prior to consent.
  • Subject agrees to all required follow-up procedures and visits.
  • Subject provides written, informed consent.
  • The target lesion is a single de novo lesion in a native coronary artery.
  • Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
  • TIMI flow of 0/1 is present at baseline and TIMI flow of 2/3 is present prior to randomization.
  • The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed after TIMI 2/3 flow is restored.
  • The entire lesion length requiring treatment is ≤33 mm by visual assessment, assessed after TIMI 2/3 flow is restored.

Exclusion Criteria:

  • Currently enrolled in another investigational device or drug trial that has not reached the primary endpoint or that clinically interferes with the current study endpoints.
  • A previous coronary interventional procedure of any kind within 30 days - - - Female patients of childbearing potential.
  • Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
  • 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).
  • Prior administration of thrombolytic therapy for the current admission
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
  • Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
  • Active or recent major bleeding within 6 months.
  • History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  • Known hypersensitivity or contraindication to i) aspirin; or ii) heparin and bivalirudin; or iii) clopidogrel, prasugrel and ticagrelor; or iv) cobalt or nickel; or v) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
  • Known calculated creatinine clearance <30 mL/min, hemoglobin <10 g/dL or platelet count <150,000 for the present admission or within 7 days prior to index procedure, if available. NOTE: Baseline labs do not have to be available to consent patient. If laboratory results become available only after randomization, and do not meet inclusion and exclusion criteria, the patient will not be de-registered from the study.
  • Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 6 months.
  • Rheolytic thrombectomy, a PTCA balloon with diameter >2.0 mm, or any other device (other than guide wire or simple manual aspiration) is required to restore TIMI 2/3 flow in the infarct vessel.
  • Unprotected left main stenosis ≥50% or planned left main intervention.
  • Any non-study lesion in the infarct artery with visually estimated diameter stenosis ≥50% and reference vessel diameter ≥2.0 mm or that will require treatment during the index procedure.
  • Multi-vessel or multi-lesion intervention required during the index procedure.
  • Excessive tortuosity, calcification or diffuse distal disease is present either proximal to, at or distal to the target lesion making it unlikely that the OCT catheter or stent will be able to reach or can be deployed across the target lesion with full expansion.
  • Target lesion is a bifurcation with a side branch ≥2.0 mm in diameter.
  • Target lesion is at the site of or within a vessel with a previously implanted stent.
  • Target lesion is within a bypass graft conduit, or can only be reached by passing the study stent through a bypass graft conduit.
  • Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by left ventriculography or any other modality (such as echocardiography, MRI, CT, physical exam).

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGuard Prime
Device: MGuard Prime
Active Comparator: Control
BMS or DES
Device: Control BMS DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the minFA as measured by OCT at end of primary PCI (after stent deployment but before postdilatation), powered to demonstrate superiority of the MGuard Prime stent compared to the control arm.
Time Frame: immediate
immediate

Collaborators and Investigators

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

Sponsor

InspireMD

Investigators

  • Principal Investigator: Ori Ben Yehuda, MD, CRF
  • Principal Investigator: Simon Eccleshall, MD, Norfolk and Norwhich Hospitals

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

October 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 29, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMD-15

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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