ST-elevation Myocardial InfarctionGUARDIANNCT01124942
MGuard Stent in ST-elevation Myocardial Infarction
A study testing MGuard net protective coronary stent and Bare-metal stent and manual thrombectomy device in people with ST-elevation Myocardial Infarction and Thrombus, run by Federico II University at 1 site in Italy.
Trial summary
The Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction, Thrombus, Stents
- What is being tested?
- MGuard net protective coronary stent and Bare-metal stent and manual thrombectomy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2010to 1 Mar 2013
- Phase
- Interventional
- 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
Who may be able to join
- >/= 18-year-old patients, willing to participate the study, after informed consent signature
- Female not pregnant or potentially child-bearing
- > 1 mV ST segment elevation in two or more contiguous leads
- Acute MI lasting more than 30 minutes and less than 12 hours
- De novo acute MI
- Infarct related artery reference vessel diameter >/= 2.5 mm
- Patient suitable for stenting according to vessel and lesion features
Who cannot join
- Dual antiplatelet therapy contraindication
- Ischemic stroke less than 30 days or previous haemorrhagic stroke
- WBC count less than 1000 per mm3;
- Platelet count less than 50.000 per mm3
- Life expectancy less than 1 year
- Cardiogenic shock at admission
Show all 13Show fewer
- Previous stented infarct related artery
- Stent thrombosis as the responsible for current STEMI
- Inability to identify infarct related artery
- True bifurcation lesion, or lesion near a side branch with a reference vessel diameter >/= 2.5 mm that could be diseased after stenting procedure
- LBBB
- Definitive pacing (or ECG abnormalities precluding ST-segment resolution evaluation
- Participation other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial
The Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions.
Read the detailed description
Embolization of thrombotic debris still represents a complication for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary interventions (PCI).
Distal embolization may decrease coronary and myocardial reperfusion after PCI in STEMI setting.
Unfortunately, intracoronary filters present several important limitations limiting their use and their efficacy especially in presence of huge amount of thrombus. In this respect, recent trials investigated whether a default manual thrombectomy strategy before stenting would ameliorate angiographic as well as clinical outcomes for STEMI patients undergoing percutaneous revascularization.
Of note, the most of embolization occurs when guidewire, and thrombectomy device cross the thrombus, and after the stent has been implanted as a consequence of plaque prolapse through the stent struts.
MGuard net protective stent, the investigational device, is a bare-metal stent covered with a ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, that is anchored to the external surface of the struts. This biocompatible fiber net (string diameter 10-22 μm) has minimal effects on the stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net and isolating the prothrombotic intima components from the blood stream.
This protocol will test the hypothesis that MGuard stent would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent PCI in terms of angiographic as well as clinical outcomes.
- Conditions
- ST-elevation Myocardial Infarction, Thrombus, Stents
- Being tested
- MGuard net protective coronary stent, Bare-metal stent and manual thrombectomy device
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGuard net protective coronary stentDevice
Also called MGuard net protective stent
It is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net.
Bare-metal stent and manual thrombectomy deviceDevice
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
| Study group | Role | What they receive |
|---|---|---|
| MGuard | Experimental | MGuard net protective stent, investigational device Receives: Device: MGuard net protective coronary stent |
| BMS plus thrombectomy | Active comparator | Bare-metal stent plus manual thrombectomy device Receives: Device: Bare-metal stent and manual thrombectomy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Myocardial Perfusional Blush Grade 2-3
Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
Measured: 30 minutes after revascularization
Secondary outcomes (8)
Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Measured: 1 month
Complete ST-segment resolution
Complete (>70%) ST-segment resolution at 60 minutes post-revascularization
Measured: 60 minutes after revascularization
Thrombolysis in myocardial infarction antegrade coronary flow
TIMI coronary flow at the end of the procedure
Measured: 30 minutes after revascularization
Corrected TIMI Frame count
Corrected TIMI Frame count at the end of the procedure
Measured: 30 minutes after revascularization
Infarct related area reduction and left ventricular ejection fraction recovery
Six-month infarct related area reduction and left ventricular ejection fraction recovery as compared with infarct related area and and left ventricular ejection fraction at admission.
Measured: 6 months
Procedural device performance
Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability
Measured: 60 minutes after revascularizationl
Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Measured: 6 months
Number of MACE
Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study start1 Mar 2010
- Primary completion1 Mar 2011
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-elevation Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esposito, Federico II University
- Investigators
- Federico Piscione, Associate Professor, Study chair, Federico II University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124942
- Sponsor's protocol ID
- NA116/09
- Acronym
- GUARDIAN
- Status last verified
- Mar 2022
- First submitted
- 8 Apr 2010
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Piscione F, Danzi GB, Cassese S, Esposito G, Cirillo P, Galasso G, Rapacciuolo A, Leosco D, Briguori C, Varbella F, Tuccillo B, Chiariello M. Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):715-21. doi: 10.1002/ccd.22292.
PubMed 19937780Rapacciuolo A, D'andrea C, Maresca G, di Pietro E, Piscione F, Chiariello M. Multiple MGuard stent implantation to treat massive right coronary artery dissection during primary coronary angioplasty. J Cardiovasc Med (Hagerstown). 2011 May;12(5):356-60. doi: 10.2459/JCM.0b013e328334092d.
PubMed 20093945
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT01124942
- Acronym / sponsor ID
- GUARDIAN / NA116/09
- Conditions
- ST-elevation Myocardial Infarction, Thrombus, Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Mar 2011 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 18 May 2010 (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 Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions.
Detailed description
Embolization of thrombotic debris still represents a complication for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary interventions (PCI).
Distal embolization may decrease coronary and myocardial reperfusion after PCI in STEMI setting.
Unfortunately, intracoronary filters present several important limitations limiting their use and their efficacy especially in presence of huge amount of thrombus. In this respect, recent trials investigated whether a default manual thrombectomy strategy before stenting would ameliorate angiographic as well as clinical outcomes for STEMI patients undergoing percutaneous revascularization.
Of note, the most of embolization occurs when guidewire, and thrombectomy device cross the thrombus, and after the stent has been implanted as a consequence of plaque prolapse through the stent struts.
MGuard net protective stent, the investigational device, is a bare-metal stent covered with a ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, that is anchored to the external surface of the struts. This biocompatible fiber net (string diameter 10-22 μm) has minimal effects on the stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net and isolating the prothrombotic intima components from the blood stream.
This protocol will test the hypothesis that MGuard stent would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent PCI in terms of angiographic as well as clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGuard | Experimental | Device: MGuard net protective coronary stentMGuard net protective stent, investigational device |
| BMS plus thrombectomy | Active comparator | Device: Bare-metal stent and manual thrombectomy deviceBare-metal stent plus manual thrombectomy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >/= 18-year-old patients, willing to participate the study, after informed consent signature
- Female not pregnant or potentially child-bearing
- > 1 mV ST segment elevation in two or more contiguous leads
- Acute MI lasting more than 30 minutes and less than 12 hours
- De novo acute MI
Key exclusion criteria (13 listed)
- Dual antiplatelet therapy contraindication
- Ischemic stroke less than 30 days or previous haemorrhagic stroke
- WBC count less than 1000 per mm3;
- Platelet count less than 50.000 per mm3
- Life expectancy less than 1 year
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 net protective coronary stentAlso: MGuard net protective stentIt is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net. | Device | MGuard |
| Bare-metal stent and manual thrombectomy deviceManual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent | Device | BMS plus thrombectomy |
Primary outcome
Number of patients with Myocardial Perfusional Blush Grade 2-3
Time frame: 30 minutes after revascularization
Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
8 secondary outcomes
Number of MACE
Time frame: 1 month
Complete ST-segment resolution
Time frame: 60 minutes after revascularization
Thrombolysis in myocardial infarction antegrade coronary flow
Time frame: 30 minutes after revascularization
Corrected TIMI Frame count
Time frame: 30 minutes after revascularization
Infarct related area reduction and left ventricular ejection fraction recovery
Time frame: 6 months
Procedural device performance
Time frame: 60 minutes after revascularizationl
Number of MACE
Time frame: 6 months
Number of MACE
Time frame: 12 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 31 Mar 2022.
- Background: PubMed 19937780Piscione F, Danzi GB, Cassese S, Esposito G, Cirillo P, Galasso G, Rapacciuolo A, Leosco D, Briguori C, Varbella F, Tuccillo B, Chiariello M. Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):715-21. doi: 10.1002/ccd.22292.
- Background: PubMed 20093945Rapacciuolo A, D'andrea C, Maresca G, di Pietro E, Piscione F, Chiariello M. Multiple MGuard stent implantation to treat massive right coronary artery dissection during primary coronary angioplasty. J Cardiovasc Med (Hagerstown). 2011 May;12(5):356-60. doi: 10.2459/JCM.0b013e328334092d.
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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.
Federico Piscione, Associate Professor study chair
Federico II University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGuard net protective coronary stent and Bare-metal stent and manual thrombectomy device in people with ST-elevation Myocardial Infarction and Thrombus, run by Federico II University at 1 site in Italy.
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 7 inclusion and 13 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Number of patients with Myocardial Perfusional Blush Grade 2-3 (time frame: 30 minutes after revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124942, which also lists 2 linked publications.
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 31 Mar 2022.