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

NCT02222116 | Withdrawn Phase 4 DMC

• 1 other identifier: IMD-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

STEMI; BMS; DES; mesh

Outcome Measures

Primary Outcomes (1)

• 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.

  immediate

Study Arms (2)

MGuard Prime

EXPERIMENTAL

MGuard Prime

Device: MGuard Prime

Control

ACTIVE COMPARATOR

BMS or DES

Device: Control BMS DES

Interventions

MGuard Prime DEVICE

MGuard Prime

Control BMS DES DEVICE

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• InspireMD: lead

Study Sites (1)

Norfolk and Norwhich Hospital

Norfolk, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Ori Ben Yehuda, MD

  CRF

  PRINCIPAL INVESTIGATOR

• Simon Eccleshall, MD

  Norfolk and Norwhich Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: October 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

GB (1)