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The Israeli MGuard Registry

This study has been completed.
Information provided by (Responsible Party):
InspireMD Identifier:
First received: June 16, 2009
Last updated: March 5, 2014
Last verified: March 2014

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major Cardiac Adverse Events rate (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Lesion success rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stent thrombosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Any death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00922337

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

No publications provided

Responsible Party: InspireMD Identifier: NCT00922337     History of Changes
Other Study ID Numbers: IMD-05
Study First Received: June 16, 2009
Last Updated: March 5, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by InspireMD:
distal embolization
thrombotic lesions

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Coronary Disease
Pathologic Processes
Signs and Symptoms
Vascular Diseases processed this record on November 20, 2014