The Israeli MGuard Registry

Acute Coronary Syndrome Clinical Trial

Official title:

A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922337
• Other study ID #: IMD-05
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: March 5, 2014
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: InspireMD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• MGuard Coronary Stent system
MGuard Coronary Stent system implanted within a PCI

Locations

Country	Name	City	State
Israel	Laniado Hospital	Natanya
Israel	Asaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
InspireMD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Cardiac Adverse Events rate (MACE)		1 month	Yes
Secondary	Major Cardiac Adverse Events rate (MACE)		6 months	Yes
Secondary	Lesion success rate		1 day	No
Secondary	Bleeding complications		6 months	No
Secondary	Stent thrombosis rate		6 months	No
Secondary	Any death		6 months	Yes