Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-01 @ 2:54 AM
Study NCT ID:
NCT02219802
Status:
UNKNOWN
Last Update Posted:
2014-08-19
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional flow reserve (FFR)', 'timeFrame': 'At 9 months follow-up', 'description': 'Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac event (MACE)', 'timeFrame': 'In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.', 'description': '1. Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.\n2. Recurrent MI in the target vessel area.\n3. Ischemia driven target lesion revascularization (PCI within 5 mm of the treated segment in case of balloon, or stent area borders in case of stent, or CABG of the target vessel).'}, {'measure': 'Angiographic endpoint: iFR', 'timeFrame': 'At 9 months follow-up.'}, {'measure': 'ST-segment resolution', 'timeFrame': '90 minutes after initial procedure', 'description': 'ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.'}, {'measure': 'Non-coronary artery bypass grafting major bleeding', 'timeFrame': 'At 1 month follow-up', 'description': '* Intracranial, intraocular, intra-articular or retroperitoneal bleeding\n* Access site bleed requiring intervention/surgery\n* Hematoma ≥ 5 cm\n* Hemoglobin (Hgb) ≥4 g/dL without an overt source\n* Hgb ≥3 g/dL with an overt source\n* Operation for bleeding\n* Any blood transfusions'}, {'measure': 'Stent thrombosis', 'timeFrame': 'During follow-up', 'description': '* Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.\n* Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.\n* Possible stent thrombosis: Unexplained death after 30 days.'}, {'measure': 'Angiographic endpoint: TIMI flow', 'timeFrame': 'At 9 months follow-up'}, {'measure': 'Angiographic endpoint: late lumen loss', 'timeFrame': 'At 9 months follow-up'}, {'measure': 'Angiographic endpoint: minimal lumen diameter', 'timeFrame': 'At 9 months follow-up'}, {'measure': 'Angiographic endpoint: diameter stenosis', 'timeFrame': 'At 9 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Acute myocardial infarction', 'Drug-coated balloon', 'Drug-eluting stent'], 'conditions': ['Coronary Artery Disease', 'Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '12517460', 'type': 'BACKGROUND', 'citation': 'Keeley EC, Boura JA, Grines CL. 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Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.'}, {'pmid': '18725485', 'type': 'BACKGROUND', 'citation': 'Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.'}, {'pmid': '21251625', 'type': 'BACKGROUND', 'citation': 'Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.'}, {'pmid': '14967732', 'type': 'BACKGROUND', 'citation': 'Hong MK, Mintz GS, Lee CW, Kim YH, Lee SW, Song JM, Han KH, Kang DH, Song JK, Kim JJ, Park SW, Park SJ. Incidence, mechanism, predictors, and long-term prognosis of late stent malapposition after bare-metal stent implantation. Circulation. 2004 Feb 24;109(7):881-6. doi: 10.1161/01.CIR.0000116751.88818.10. Epub 2004 Feb 16.'}, {'pmid': '19463469', 'type': 'BACKGROUND', 'citation': '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. 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EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101.'}, {'pmid': '8124786', 'type': 'BACKGROUND', 'citation': 'De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.'}, {'pmid': '8637515', 'type': 'BACKGROUND', 'citation': 'Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.'}, {'pmid': '11447079', 'type': 'BACKGROUND', 'citation': 'De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. 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J Am Coll Cardiol. 1986 Nov;8(5):1022-32. doi: 10.1016/s0735-1097(86)80377-1.'}, {'pmid': '3403826', 'type': 'BACKGROUND', 'citation': 'Zijlstra F, Fioretti P, Reiber JH, Serruys PW. Which cineangiographically assessed anatomic variable correlates best with functional measurements of stenosis severity? A comparison of quantitative analysis of the coronary cineangiogram with measured coronary flow reserve and exercise/redistribution thallium-201 scintigraphy. J Am Coll Cardiol. 1988 Sep;12(3):686-91. doi: 10.1016/s0735-1097(88)80057-3.'}, {'pmid': '20579537', 'type': 'BACKGROUND', 'citation': "Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096."}, {'pmid': '21481828', 'type': 'BACKGROUND', 'citation': 'Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.'}, {'pmid': '15657233', 'type': 'BACKGROUND', 'citation': 'Klauss V, Erdin P, Rieber J, Leibig M, Stempfle HU, Konig A, Baylacher M, Theisen K, Haufe MC, Sroczynski G, Schiele T, Siebert U. Fractional flow reserve for the prediction of cardiac events after coronary stent implantation: results of a multivariate analysis. Heart. 2005 Feb;91(2):203-6. doi: 10.1136/hrt.2003.027797.'}, {'pmid': '22154731', 'type': 'BACKGROUND', 'citation': 'Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.'}, {'pmid': '24211503', 'type': 'BACKGROUND', 'citation': "Jeremias A, Maehara A, Genereux P, Asrress KN, Berry C, De Bruyne B, Davies JE, Escaned J, Fearon WF, Gould KL, Johnson NP, Kirtane AJ, Koo BK, Marques KM, Nijjer S, Oldroyd KG, Petraco R, Piek JJ, Pijls NH, Redwood S, Siebes M, Spaan JAE, van 't Veer M, Mintz GS, Stone GW. Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study. J Am Coll Cardiol. 2014 Apr 8;63(13):1253-1261. doi: 10.1016/j.jacc.2013.09.060. Epub 2013 Nov 6."}, {'pmid': '19717185', 'type': 'BACKGROUND', 'citation': 'Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.'}, {'pmid': '19801025', 'type': 'BACKGROUND', 'citation': 'Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.'}, {'pmid': '22922416', 'type': 'BACKGROUND', 'citation': "Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available."}, {'pmid': '31126887', 'type': 'DERIVED', 'citation': 'Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.\n\nObjective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).', 'detailedDescription': 'Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.\n\nObjective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).\n\nStudy design: This is a prospective, single center, non-inferiority, randomized controlled trial.\n\nStudy population: All patients presenting with STEMI and suitable for PPCI.\n\nIntervention: PPCI will be performed according to current guidelines. After thrombus aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be administered according current standards. Control coronary angiography, including measurement of the fractional flow reserve (FFR) of the treated lesion(s), will be performed after 9 months.\n\nMain study parameters/endpoints: The main study parameter is the fractional flow reserve at 9 months follow-up. Secondary study parameters include cardiac death, recurrent myocardial infarction in the target vessel area and ischemia driven target lesion revascularisation at 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myocardial infarction eligible for primary PCI:\n* \\> 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography)\n* Reperfusion is expected to be feasible within 12 hours after onset of complaints\n* Infarct related artery eligible for PPCI and:\n* De novo lesion in a native coronary artery\n* Reference-vessel diameter ≥ 2.5mm and ≤ 4mm\n* Without severe calcification\n* Without diameter stenosis of \\>50% (by visual assessment) after thrombus aspiration and pre-dilatation.\n\nThe protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.\n\nExclusion Criteria:\n\n* Age \\< 18 years and \\> 75 years\n* History of myocardial infarction\n* Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor.\n* Participation in another clinical study, interfering with this protocol\n* Uncertain neurological outcome e.g. resuscitation\n* Intubation/ventilation\n* Cardiogenic shock prior to randomization\n* Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA \\< 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)\n* Gastro-intestinal / urinary tract bleeding \\< 2 months prior to inclusion\n* Refusal to receive blood transfusion\n* Planned major surgery within 6 weeks\n* Stent implantation \\< 1 month prior to inclusion\n* Expected mortality from any cause within the next 12 months'}, 'identificationModule': {'nctId': 'NCT02219802', 'acronym': 'REVELATION', 'briefTitle': 'Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouwe Gasthuis'}, 'officialTitle': 'Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'NL48495.100.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug-eluting stent', 'description': 'Treatment of infarct related laesion with a drug-eluting stent', 'interventionNames': ['Procedure: Treatment according arm']}, {'type': 'EXPERIMENTAL', 'label': 'Drug-coated balloon', 'description': 'After treatment of the infarct related artery with a drug-coated ballon, an additional BMS is advised to be used in case of residual stenosis \\> 50% or coronary artery dissection type \\> B.', 'interventionNames': ['Procedure: Treatment according arm']}], 'interventions': [{'name': 'Treatment according arm', 'type': 'PROCEDURE', 'armGroupLabels': ['Drug-coated balloon', 'Drug-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'contacts': [{'name': 'R. J. van der Schaaf, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'R. J. van der Schaaf, MD, PhD', 'role': 'CONTACT', 'email': 'r.j.vanderschaaf@olvg.nl', 'phone': '+31-20-5992387'}, {'name': 'N. S. Vos, MD', 'role': 'CONTACT', 'email': 'n.s.vos@olvg.nl', 'phone': '+13-20-5992387'}], 'overallOfficials': [{'name': 'R. J. van der Schaaf, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OLVG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouwe Gasthuis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, {'name': 'Volcano Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'J.P.R.Herrman, MD, PhD', 'investigatorFullName': 'J.P.R. Herrman', 'investigatorAffiliation': 'Onze Lieve Vrouwe Gasthuis'}}}}