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The Israeli MGuard Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922337
First Posted: June 17, 2009
Last Update Posted: March 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InspireMD
  Purpose
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

Condition Intervention
Ischemic Heart Disease Acute Coronary Syndrome Acute Myocardial Infarction Device: MGuard Coronary Stent system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System

Further study details as provided by InspireMD:

Primary Outcome Measures:
  • Major Cardiac Adverse Events rate (MACE) [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Major Cardiac Adverse Events rate (MACE) [ Time Frame: 6 months ]
  • Lesion success rate [ Time Frame: 1 day ]
  • Bleeding complications [ Time Frame: 6 months ]
  • Stent thrombosis rate [ Time Frame: 6 months ]
  • Any death [ Time Frame: 6 months ]

Enrollment: 86
Study Start Date: July 2009
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MGuard
eligible patients implanted with minimum one MGuard stent
Device: MGuard Coronary Stent system
MGuard Coronary Stent system implanted within a PCI
Other Name: MGuard

Detailed Description:

A Prospective, Observational, Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a "real world" patient population requiring stent implantation.

The secondary objective is to assess the event rate in patient subgroups with specific clinical indications and/or vessel and/or lesion characteristics.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an indication for coronary stent implantation according to the Israeli regulatory approval of the MGuard Coronary Stent System. All patients who receive one or more MGuard Coronary Stent System in one or more target lesions should be included.
Criteria

Inclusion Criteria:

  • Patient is > 18 years of age
  • The patient has consented to participate by signing the "Patient Informed Consent Form"
  • Patient is suitable for implantation of one or more MGuard Stent System in one or more target lesions
  • Target lesion(s) are according to the Indications for Use and Israeli regulatory approval of the MGuard Stent System
  • The patient is willing and able to cooperate with registry procedures and required follow up

Exclusion Criteria:

  • Heavily calcified target lesions
  • Target lesions with side branch bigger then 2.5mm
  • Target lesions which are distal to newly stented lesion (less than 1 month).
  • Women with known pregnancy
  • Current medical condition with a life expectancy of less than 12 months
  • Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits study participation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922337


Locations
Israel
Laniado Hospital
Natanya, Israel
Asaf Harofe Medical Center
Zrifin, Israel
Sponsors and Collaborators
InspireMD
Investigators
Study Director: Elad Yaacoby InspireMD
  More Information

Responsible Party: InspireMD
ClinicalTrials.gov Identifier: NCT00922337     History of Changes
Other Study ID Numbers: IMD-05
First Submitted: June 16, 2009
First Posted: June 17, 2009
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by InspireMD:
distal embolization
thrombotic lesions
AMI
ACS
SVG

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases