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Coronary DiseaseGUARDIANCORYNCT03087175

MGuard Stent and Microcirculation

A study testing MGuard stent and Drug eluting stent and bare metal stent in people with Coronary Disease and Coronary Artery Disease, run by University Hospital, Grenoble at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MGuard stent and Drug eluting stent and bare metal stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesFrance
Study dates
Dec 2016to 13 Nov 2019
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

  • 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.

Who cannot join

  • 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),
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Annecy Hospital

    Annecy

  • University Hospital Grenoble

    Grenoble

Other trials in France

About this study

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)

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.

Read more

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.

Read the detailed 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.

Being tested
MGuard stent, Drug eluting stent and bare metal stent
Medical subject headings
Coronary Disease, Coronary Artery Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MGuard stentDevice

    Also called MGuard micronet mesh-covered stent

    MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS

  • Drug eluting stent and bare metal stentDevice

    Also called Resolute Onyx

    Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx

Study groups in NCT03087175
Study groupRoleWhat they receive
MGuard stentExperimentalMGuard stent is a novel thin-strut metal stent with a polyethylene terephthalate micronet covering designed to trap and exclude thrombus and friable atheromatous debris to prevent distal embolization
Receives: Device: MGuard stent
Drug eluting stent and bare metal stentActive comparatorDrug eluting stent and bare metal stent
Receives: Device: Drug eluting stent and bare metal stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Index of microcirculatory resistance (IMR)

    Index of microcirculatory resistance (IMR) will be measured with a pressure sensor/thermistor-tipped guidewire

    Measured: During the 2 hours after randomization

Secondary outcomes (9)

  1. TIMI flux on angiography

    Measured: During the 2 hours after randomization

  2. Grade blush on angiography

    Measured: During the 2 hours after randomization

  3. TIMI frame count measure

    Measured: During the 2 hours after randomization

  4. Measure of risk area by BARI-Score

    Measured: During the 2 hours after randomisation

  5. ST-segment resolution defined by >70% ST-segment resolution on EKG post angioplasty compared to initial EKG

    Measured: During the 24 hours after randomization

  6. Enzymatic cycle with measure of troponin T and CPK pick

    Measured: 7 days after randomization

  7. Measure of wall motion score (WMS) by echocardiography

    Measured: 2, 7 days after randomization, 6 month follow-up

  8. Measure of 2D strain by echocardiography

    Measured: 2, 7 days after randomization, 6 month follow-up

  9. Cardiological follow up to detect intrastent restenosis

    Measured: 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study startDec 2016
  3. Primary completion7 Nov 2019
  4. Study completion13 Nov 2019

Resources

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087175
Sponsor's protocol ID
38RC15.311
Acronym
GUARDIANCORY
Status last verified
May 2022
First submitted
14 Nov 2016
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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. No abstract available.

    PubMed 26320110

  • Silen W, Machen TE, Forte JG. Acid-base balance in amphibian gastric mucosa. Am J Physiol. 1975 Sep;229(3):721-30. doi: 10.1152/ajplegacy.1975.229.3.721.

    PubMed 2015

  • 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.

    PubMed 22995880

  • 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. doi: 10.1016/j.ahj.2006.04.016.

    PubMed 16996854

  • Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, Antman EM, Braunwald E; TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001 May 29;103(21):2550-4. doi: 10.1161/01.cir.103.21.2550.

    PubMed 11382722

  • De Bruyne B, Pijls NH, Smith L, Wievegg M, Heyndrickx GR. Coronary thermodilution to assess flow reserve: experimental validation. Circulation. 2001 Oct 23;104(17):2003-6. doi: 10.1161/hc4201.099223.

    PubMed 11673336

  • Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, Lopez-Sendon J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. doi: 10.1161/01.CIR.0000109691.16944.DA. Epub 2004 Jan 26.

    PubMed 14744970

  • Cuisset T, Hamilos M, Melikian N, Wyffels E, Sarma J, Sarno G, Barbato E, Bartunek J, Wijns W, De Bruyne B. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation. J Am Coll Cardiol. 2008 Mar 18;51(11):1060-5. doi: 10.1016/j.jacc.2007.11.059.

    PubMed 18342222

  • Holm J, Haggendal E, Lundberg D, Schersten T, Stenberg K, Wetterqvist H. Effect of lumbar sympathetic blockade and chlorpromazine-induced adrenergic alpha-receptor blockade on skin temperature in peripheral arterial diseases. J Cardiovasc Surg (Torino). 1976 Jan-Feb;17(1):69-71.

    PubMed 1398

  • Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. doi: 10.1161/01.CIR.0000143893.18451.0E. Epub 2004 Oct 4.

    PubMed 15466646

  • 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.

    PubMed 18617066

  • 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. doi: 10.1053/euhj.2001.3035.

    PubMed 12090749

  • 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.

    PubMed 23453107

  • 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. doi: 10.1161/CIRCULATIONAHA.105.603522. Epub 2006 Apr 24.

    PubMed 16636168

  • 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. doi: 10.1161/01.CIR.0000080700.98607.D1. Epub 2003 Jun 23.

    PubMed 12821539

Questions about this trial

What is this clinical trial studying?

A study testing MGuard stent and Drug eluting stent and bare metal stent in people with Coronary Disease and Coronary Artery Disease, run by University Hospital, Grenoble at 2 sites in France.

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 6 inclusion and 12 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 25 May 2022. 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 France. 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?

Index of microcirculatory resistance (IMR) (time frame: During the 2 hours after randomization). 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 NCT03087175, which also lists 23 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 25 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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