The Israeli MGuard Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InspireMD
ClinicalTrials.gov Identifier:
NCT00922337
First received: June 16, 2009
Last updated: March 5, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


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
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

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.

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: InspireMD
ClinicalTrials.gov 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
AMI
ACS
SVG

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014