MGuard Stent in ST-elevation Myocardial Infarction (GUARDIAN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Federico II University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01124942
First received: April 8, 2010
Last updated: May 17, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
ST-Elevation Myocardial Infarction
Thrombus
Stents
Device: MGuard net protective coronary stent
Device: Bare-metal stent and manual thrombectomy device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Number of patients with Myocardial Perfusional Blush Grade 2-3 [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
    Myocardial Perfusional Blush Grade 2-3 at the end of the procedure


Secondary Outcome Measures:
  • Number of MACE [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.

  • Complete ST-segment resolution [ Time Frame: 60 minutes after revascularization ] [ Designated as safety issue: No ]
    Complete (>70%) ST-segment resolution at 60 minutes post-revascularization

  • Thrombolysis in myocardial infarction antegrade coronary flow [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
    TIMI coronary flow at the end of the procedure

  • Corrected TIMI Frame count [ Time Frame: 30 minutes after revascularization ] [ Designated as safety issue: No ]
    Corrected TIMI Frame count at the end of the procedure

  • Infarct related area reduction and left ventricular ejection fraction recovery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Procedural device performance [ Time Frame: 60 minutes after revascularizationl ] [ Designated as safety issue: No ]
    Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability

  • Number of MACE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.

  • Number of MACE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.


Estimated Enrollment: 350
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGuard
MGuard net protective stent, investigational device
Device: MGuard net protective coronary 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.
Other Name: MGuard net protective stent
Active Comparator: BMS plus thrombectomy
Bare-metal stent plus manual thrombectomy device
Device: Bare-metal stent and manual thrombectomy device
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >/= 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124942

Contacts
Contact: Giovanni Esposito, MD 0817462216 ext 0039 espogiov@unina.it

Locations
Italy
Federico II University of Naples Recruiting
Naples, Italy, 80131
Contact: Giovanni Esposito, MD    0817462216 ext 0039    espogiov@unina.it   
Principal Investigator: Giovanni Esposito, MD PhD         
Principal Investigator: Federico Piscione, Associate Professor         
Sponsors and Collaborators
Federico II University
Investigators
Study Chair: Federico Piscione, Associate Professor Federico II University of Naples
  More Information

Publications:
Responsible Party: Giovanni Esposito, MD PhD, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier: NCT01124942     History of Changes
Other Study ID Numbers: NA116/09
Study First Received: April 8, 2010
Last Updated: May 17, 2010
Health Authority: Italy: Ministry of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on August 18, 2014