MGuard Stent and Microcirculation

Coronary Artery Disease Clinical Trial

— GUARDIANCORY  

Official title:

Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) on Coronary Microcirculation's Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction (STE and NSTE-ACS): Assessment by Index of Microcirculatory Resistance (IMR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087175
• Other study ID #: 38RC15.311
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: November 13, 2019

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary microcirculation lesions. This complication is related to poor prognosis.

MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction.

Index of microcirculatory resistance (IMR) is a validated method to assess coronary microcirculation.

Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with NSTE-ACS, assessed by Index of microcirculatory resistance.

Description:

GUARDIANCORY study is a multicentre, prospective, randomized, non inferiority, open-label trial with a planned inclusion of 52 patients with STE and NSTE ACS and prescribed PCI. Patients will be randomized to benefiting either DES /BMS implantation (n=26) or MGuard stent (n=26) on the culprit lesion. Assessment of coronary microcirculation will be done by IMR immediately after PCI by using a pressure-temperature sensor-tipped coronary wire, thermodilution-derived.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 13, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patients affiliated to social security

• Patients with an NSTEMI or STEMI (1)

• Thrombus containing coronary lesions on angiography (TIMI thrombus grade = 3)

• Eligible patients for revascularization with angioplasty

• Patients consenting to participate in the study.

Exclusion Criteria:

• Age < 18 years

• Prior myocardial infarction

• Prior CABG

• Inability to comply with the protocol

• Major patient protected by law (article L1121-8),

• Person deprived of liberty (article L1121-8),

• Pregnant woman

• Breastfeeding women

• Patient with terminal illness,

• Terminal Renal failure

• Allergy to iodine

• Adenosine's contraindications: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome. Systolic blood pressure less than 90mmHg. Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test. Known hypersensitivity to adenosine. Unstable acute myocardial infarction or acute coronary syndrome.

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• MGuard stent
MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
• Drug eluting stent and bare metal stent
Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx

Locations

Country	Name	City	State
France	Annecy Hospital	Annecy
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (23)

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Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. Epub 2003 Jun 23. Erratum in: Circulation. 2003 Dec 23;108(25):3165. — View Citation

Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16. — View Citation

Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062. — View Citation

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Gibson CM, Kirtane AJ, Morrow DA, Palabrica TM, Murphy SA, Stone PH, Scirica BM, Jennings LK, Herrmann HC, Cohen DJ, McCabe CH, Braunwald E; TIMI Study Group. Association between thrombolysis in myocardial infarction myocardial perfusion grade, biomarkers, and clinical outcomes among patients with moderate- to high-risk acute coronary syndromes: observations from the randomized trial to evaluate the relative PROTECTion against post-PCI microvascular dysfunction and post-PCI ischemia among antiplatelet and antithrombotic agents-Thrombolysis In Myocardial Infarction 30 (PROTECT-TIMI 30). Am Heart J. 2006 Oct;152(4):756-61. — View Citation

Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7. — View Citation

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Kaul P, Ezekowitz JA, Armstrong PW, Leung BK, Savu A, Welsh RC, Quan H, Knudtson ML, McAlister FA. Incidence of heart failure and mortality after acute coronary syndromes. Am Heart J. 2013 Mar;165(3):379-85.e2. doi: 10.1016/j.ahj.2012.12.005. Epub 2013 Jan 22. — View Citation

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Napodano M, Ramondo A, Tarantini G, Peluso D, Compagno S, Fraccaro C, Frigo AC, Razzolini R, Iliceto S. Predictors and time-related impact of distal embolization during primary angioplasty. Eur Heart J. 2009 Feb;30(3):305-13. doi: 10.1093/eurheartj/ehn594. Epub 2009 Jan 19. — View Citation

Ng MK, Yeung AC, Fearon WF. Invasive assessment of the coronary microcirculation: superior reproducibility and less hemodynamic dependence of index of microcirculatory resistance compared with coronary flow reserve. Circulation. 2006 May 2;113(17):2054-61. Epub 2006 Apr 24. — View Citation

Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006. — View Citation

Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007. — View Citation

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. — View Citation

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Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyla R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of microcirculatory resistance (IMR)	Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire	During the 2 hours after randomization
Secondary	TIMI flux on angiography		During the 2 hours after randomization
Secondary	Grade blush on angiography		During the 2 hours after randomization
Secondary	TIMI frame count measure		During the 2 hours after randomization
Secondary	Measure of risk area by BARI-Score		During the 2 hours after randomisation
Secondary	ST-segment resolution defined by >70% ST-segment resolution on EKG post angioplasty compared to initial EKG		During the 24 hours after randomization
Secondary	Enzymatic cycle with measure of troponin T and CPK pick		7 days after randomization
Secondary	Measure of wall motion score (WMS) by echocardiography		2, 7 days after randomization, 6 month follow-up
Secondary	Measure of 2D strain by echocardiography		2, 7 days after randomization, 6 month follow-up
Secondary	Cardiological follow up to detect intrastent restenosis		6 month follow-up