Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients (TROFI)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Terumo Europe N.V.

ClinicalTrials.gov Identifier:

NCT01271361

First received: January 5, 2011

Last updated: December 6, 2012

Last verified: December 2012

History of Changes

Purpose

The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.

Condition	Intervention	Phase
Coronary Artery Disease Myocardial Infarction STEMI	Procedure: primary PCI with thrombectomy Procedure: primary PCI without thrombectomy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Attack

U.S. FDA Resources

Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:

minimal flow area assessed by OFDI [ Time Frame: at baseline procedure (post-stenting) ] [ Designated as safety issue: No ]
Flow area is defined as: (Stent area + incomplete stent apposition area) - (intraluminal defect area attached to the wall + intraluminal defect area free from the wall)

Secondary Outcome Measures:

normalised minimal flow area [ Time Frame: at baseline procedure (post stenting) ] [ Designated as safety issue: No ]
defined as the ratio of minimal flow divided by stent area at the site of the minimal flow area
mean flow area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
intraluminal defect area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
mean stent area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
percent of malapposed struts [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
incomplete stent apposition (ISA) area/volume [ Time Frame: at baseline procedure (post stenting) and at 6 months ] [ Designated as safety issue: No ]
percent of struts with coverage [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
healing index [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
tissues prolapse area/volume [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
procedure success [ Time Frame: at baseline procedure ] [ Designated as safety issue: No ]
attainment of <30% residual stenosis of the target lesion and no in-hospital target vessel failure
target vessel failure [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
defined as cardiac death, reinfarction in the territory of infarction related vessel (Q wave and non-Q wave), or clinically driven target vessel revascularization - and its individual components
all-cause mortality [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
cardiac death, non-cardiovascular death, vascular death [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
any myocardial (re)infarction [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
target vessel revascularization [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
stent thrombosis according to ARC definition [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]
other serious adverse events (SAEs) [ Time Frame: at discharge, 1 month, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	140
Study Start Date:	November 2010
Study Completion Date:	December 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: primary PCI with thrombectomy thrombectomy before implantation of drug eluting stent	Procedure: primary PCI with thrombectomy thrombectomy is performed before implantation of a drug eluting stent Other Names: Eliminate thrombectomy device Nobori Biolimus A9 drug-eluting stent
Active Comparator: primary PCI without thrombectomy implantation of a drug eluting stent without thrombectomy	Procedure: primary PCI without thrombectomy no thrombectomy is performed before the implantation of a drug eluting stent Other Name: Nobori Biolimus A9 drug-eluting stent

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Patient is at least 18 years of age.
Patients with a ST-elevation Myocardial Infarction documented in an ambulance or in a Cathlab with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographical visible stenosis (>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
The single vessel coronary artery disease.
Signed Informed Consent.
The patient understands and accepts clinical follow-up and OFDI controls.
Patients residence is in the area covered by hospital. Angiographic
Vessel size should match available Nobori stent sizes (<4.0 mm, and >2.0 mm by visual assessment).

Additional Inclusion criteria (applicable only for France)

Patients residence is in the area covered by hospital.
Patient is affiliated to social security or equivalent system.

Exclusion Criteria:

Pregnancy and women of child bearing potential (less than 50 years of age).
Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
Diameter Stenosis <30% in the target lesion.
The multi-vessel coronary artery disease (DS>50%).
Unprotected left main disease with a diameter stenosis of >30% by visual assessment.
Distal vessel occlusion.
Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter.
Fibrinolysis prior to PCI.
Known thrombocytopaenia (PLT< 100,000/mm3).
Contraindication to PCI, stenting, ASA, clopidogrel.
Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
Cardiogenic Shock.
Significant comorbidities precluding clinical follow-up (as judged by investigators).
Major planned surgery that requires discontinuation of dual antiplatelet therapy.
Proximal RCA stenosis (>30%) if the infarct-related artery is mid-RCA or distal-RCA.
People under judicial protection.
A patient who has congenital heart disease, severe cardiac valve disorder and/or myocardial disease (excluding status post MI).
Patient participating in other clinical research study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271361

Locations

Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
France
Clinique Pasteur
Toulouse, France, 31076
Germany
Universität Leipzig - Herzzentrum
Leipzig, Germany, 04289
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000CA
Maastad Hospital
Rotterdam, Netherlands, 3015EA

Sponsors and Collaborators

Terumo Europe N.V.

Investigators

Principal Investigator:

Patrick W Serruys, MD

Erasmus Medical Center, Rotterdam, Netherlands

More Information

Publications:

Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. Epub 2008 Nov 12. No abstract available.

Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9.

Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56.

Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. Epub 2007 Jul 30.

Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg RT, Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients with ST-elevation myocardial infarction and large thrombus burden: the Thoraxcenter experience. J Invasive Cardiol. 2006 Jul;18 Suppl C:3C-7C.

Haeck JD, Koch KT, Bilodeau L, Van der Schaaf RJ, Henriques JP, Vis MM, Baan J Jr, Van der Wal AC, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ. Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study. JACC Cardiovasc Interv. 2009 Oct;2(10):934-43.

Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31.

Vlaar PJ, Svilaas T, Vogelzang M, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan E, Suurmeijer AJ, Zijlstra F. A comparison of 2 thrombus aspiration devices with histopathological analysis of retrieved material in patients presenting with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2008 Jun;1(3):258-64.

Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15.

Sardella G, Mancone M, Nguyen BL, De Luca L, Di Roma A, Colantonio R, Petrolini A, Conti G, Fedele F. The effect of thrombectomy on myocardial blush in primary angioplasty: the Randomized Evaluation of Thrombus Aspiration by two thrombectomy devices in acute Myocardial Infarction (RETAMI) trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):84-91.

Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. Epub 2006 Sep 26.

Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design. Am Heart J. 2006 Mar;151(3):597.e1-597.e7.

Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6.

De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J. 2008 Dec;29(24):3002-10. Epub 2008 Sep 5. Review.

Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrié D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8.

Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20.

Kubo T, Imanishi T, Takarada S, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Kitabata H, Tsuda K, Tomobuchi Y, Akasaka T. Assessment of culprit lesion morphology in acute myocardial infarction: ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. J Am Coll Cardiol. 2007 Sep 4;50(10):933-9. Epub 2007 Aug 20.

Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52.

Hara H, Nakamura M, Komatsu H, Ikeda N, Shinji H, Makino K, Itaya H, Yamamoto M, Itou N, Tsunoda T, Sugi K. Comparison of the in vitro performance of 6 and 7 French aspiration catheters. EuroIntervention. 2007 Feb;2(4):487-92.

Grayson AD, Moore RK, Jackson M, Rathore S, Sastry S, Gray TP, Schofield I, Chauhan A, Ordoubadi FF, Prendergast B, Stables RH; North West Quality Improvement Programme in Cardiac Interventions. Multivariate prediction of major adverse cardiac events after 9914 percutaneous coronary interventions in the north west of England. Heart. 2006 May;92(5):658-63. Epub 2005 Sep 13.

Guédès A, Keller PF, L'Allier PL, Lespérance J, Grégoire J, Tardif JC. Long-term safety of intravascular ultrasound in nontransplant, nonintervened, atherosclerotic coronary arteries. J Am Coll Cardiol. 2005 Feb 15;45(4):559-64.

Johansson P, Lundén M, Ekström L, Grip L, Wennerblom B. Intensive use of intravascular ultrasound during coronary angioplasty. A six-month campaign. Scand Cardiovasc J. 2001 Mar;35(2):75-9.

Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S, Serruys PW. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010 Feb;5(7):871-4. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Muramatsu T, García-García HM, Lee IS, Bruining N, Onuma Y, Serruys PW. Quantitative optical frequency domain imaging assessment of in-stent structures in patients with ST-segment elevation myocardial infarction: impact of imaging sampling rate. Circ J. 2012;76(12):2822-31. Epub 2012 Aug 29.

Responsible Party:	Terumo Europe N.V.
ClinicalTrials.gov Identifier:	NCT01271361 History of Changes
Other Study ID Numbers:	T114E4
Study First Received:	January 5, 2011
Last Updated:	December 6, 2012
Health Authority:	Netherlands: Dutch Health Care Inspectorate Netherlands: Medical Ethics Review Committee (METC) France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee France: Conseil National de l'Ordre des Médecins France: French Data Protection Authority Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Denmark: Danish Medicines Agency Denmark: Ethics Committee

Keywords provided by Terumo Europe N.V.:

thrombus aspiration
Drug-Eluting Stent
optical frequency domain imaging (OFDI)

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Thrombosis
Heart Diseases
Cardiovascular Diseases

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Embolism and Thrombosis

ClinicalTrials.gov processed this record on May 19, 2013

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