Status:
COMPLETED
The Israeli MGuard Registry
Lead Sponsor:
InspireMD
Conditions:
Ischemic Heart Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System
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 worl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00922337
Start Date
July 1 2009
End Date
December 1 2013
Last Update
March 6 2014
Active Locations (2)
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1
Laniado Hospital
Netanya, Israel
2
Asaf Harofe Medical Center
Zrifin, Israel