Ischemic Heart DiseaseNCT00922337
The Israeli MGuard Registry
An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by InspireMD at 2 sites in Israel.
Trial summary
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Acute Coronary Syndrome, Acute Myocardial Infarction
- What is being tested?
- MGuard Coronary Stent system
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System
the objective of the Israeli MGurad Registry is to evaluate the 'Real World' Clinical Performance of the InspireMD MGuard Coronary Stent System
Read the 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.
- Being tested
- MGuard Coronary Stent system
- Keywords
- distal embolization, thrombotic lesions, AMI, ACS, SVG
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGuard Coronary Stent systemDevice
Also called MGuard
MGuard Coronary Stent system implanted within a PCI
| Study group | Role | What they receive |
|---|---|---|
| MGuard | eligible patients implanted with minimum one MGuard stent Receives: Device: MGuard Coronary Stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Cardiac Adverse Events rate (MACE)
Measured: 1 month
Secondary outcomes (5)
Major Cardiac Adverse Events rate (MACE)
Measured: 6 months
Lesion success rate
Measured: 1 day
Bleeding complications
Measured: 6 months
Stent thrombosis rate
Measured: 6 months
Any death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- InspireMD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elad Yaacoby, Study director, InspireMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922337
- Sponsor's protocol ID
- IMD-05
- Status last verified
- Mar 2014
- First submitted
- 16 Jun 2009
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicenter Registry To Evaluate the 'Real World' Clinical Performance of the MGuard Coronary Stent System
- ClinicalTrials.gov ID
- NCT00922337
- Acronym / sponsor ID
- IMD-05
- Keywords
- distal embolization, thrombotic lesions, AMI, ACS, SVG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- InspireMDIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MGuard | – | Device: MGuard Coronary Stent systemeligible patients implanted with minimum one MGuard stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGuard Coronary Stent systemAlso: MGuardMGuard Coronary Stent system implanted within a PCI | Device | MGuard |
Primary outcome
Major Cardiac Adverse Events rate (MACE)
Time frame: 1 month
5 secondary outcomes
Major Cardiac Adverse Events rate (MACE)
Time frame: 6 months
Lesion success rate
Time frame: 1 day
Bleeding complications
Time frame: 6 months
Stent thrombosis rate
Time frame: 6 months
Any death
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elad Yaacoby study director
InspireMD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by InspireMD at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Cardiac Adverse Events rate (MACE) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.