The Israeli MGuard Registry
A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System
1 other identifier
observational
86
1 country
2
Brief Summary
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 6, 2014
March 1, 2014
3.9 years
June 16, 2009
March 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Cardiac Adverse Events rate (MACE)
1 month
Secondary Outcomes (5)
Major Cardiac Adverse Events rate (MACE)
6 months
Lesion success rate
1 day
Bleeding complications
6 months
Stent thrombosis rate
6 months
Any death
6 months
Study Arms (1)
MGuard
eligible patients implanted with minimum one MGuard stent
Interventions
MGuard Coronary Stent system implanted within a PCI
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InspireMDlead
Study Sites (2)
Laniado Hospital
Netanya, Israel
Asaf Harofe Medical Center
Zrifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elad Yaacoby
InspireMD
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
March 6, 2014
Record last verified: 2014-03