Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT04881812
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2021-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with a CTO who are eligible for PCI will be randomized in a 1:1 ratio to additional DCB treatment or stenting of residual disease.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tertiary outcome', 'timeFrame': '1 year', 'description': 'As measured in CCTA substudy:\n\n* Percent diameter stenosis (%)\n* In-segment binary restenosis (\\>50%)\n* Target vessel re-occlusion (yes/no)'}], 'primaryOutcomes': [{'measure': 'In-segment diameter stenosis', 'timeFrame': '1 year', 'description': 'The primary outcome is to investigate percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS).'}], 'secondaryOutcomes': [{'measure': 'Invasive', 'timeFrame': '1 year', 'description': '* Minimal lumen diameter (millimeters)\n* Late luminal loss (millimeters)\n* In-segment binary restenosis (\\>50%)\n* Target vessel re-occlusion (yes/no)'}, {'measure': 'Clinical (MACE)', 'timeFrame': '1 year', 'description': 'Major adverse cardiac events (MACE). MACE is composite endpoint of cardiac death, non-fatal myocardial infarction and ischemia driven target lesion revascularization (ID-TLR)'}, {'measure': 'Clinical (angina)', 'timeFrame': 'At inclusion and 1-year follow-up', 'description': 'Occurrence of angina pectoris according to the Canadian Cardiovascular Society Grading Scale (grade 1-4):\n\n1. Angina only during strenuous or prolonged physical activity;\n2. Slight limitation, with angina only during vigorous physical activity;\n3. Symptoms with everyday living activities, i.e. marked limitation;\n4. Inability to perform any activity without angina or angina at rest, i.e. severe limitation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-coated balloon', 'Drug-eluting stent', 'Randomized controlled trial', 'PCI'], 'conditions': ['Chronic Total Occlusion of Coronary Artery']}, 'referencesModule': {'references': [{'pmid': '26189193', 'type': 'BACKGROUND', 'citation': 'Christopoulos G, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman RM, Lombardi WL, Menon RV, Grantham JA, Kandzari DE, Lembo N, Moses JW, Kirtane AJ, Parikh M, Green P, Finn M, Garcia S, Doing A, Patel M, Bahadorani J, Tarar MN, Christakopoulos GE, Thompson CA, Banerjee S, Brilakis ES. Application and outcomes of a hybrid approach to chronic total occlusion percutaneous coronary intervention in a contemporary multicenter US registry. Int J Cardiol. 2015 Nov 1;198:222-8. doi: 10.1016/j.ijcard.2015.06.093. Epub 2015 Jun 27.'}, {'pmid': '27788851', 'type': 'BACKGROUND', 'citation': 'Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe: The RECHARGE Registry. J Am Coll Cardiol. 2016 Nov 1;68(18):1958-1970. doi: 10.1016/j.jacc.2016.08.034.'}, {'pmid': '17321312', 'type': 'BACKGROUND', 'citation': 'Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.'}, {'pmid': '20170876', 'type': 'BACKGROUND', 'citation': 'Fearon WF. Impact of drug-eluting stent length on outcomes less is more...more or less. JACC Cardiovasc Interv. 2010 Feb;3(2):189-90. doi: 10.1016/j.jcin.2009.12.006. No abstract available.'}, {'pmid': '20398864', 'type': 'BACKGROUND', 'citation': 'Suh J, Park DW, Lee JY, Jung IH, Lee SW, Kim YH, Lee CW, Cheong SS, Kim JJ, Park SW, Park SJ. The relationship and threshold of stent length with regard to risk of stent thrombosis after drug-eluting stent implantation. JACC Cardiovasc Interv. 2010 Apr;3(4):383-9. doi: 10.1016/j.jcin.2009.10.033.'}, {'pmid': '30667361', 'type': 'BACKGROUND', 'citation': 'Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534. doi: 10.4244/EIJY19M01_01. No abstract available.'}, {'pmid': '30170854', 'type': 'BACKGROUND', 'citation': 'Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.'}, {'pmid': '31204115', 'type': 'BACKGROUND', 'citation': 'Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.'}, {'pmid': '23982467', 'type': 'BACKGROUND', 'citation': 'Kleber FX, Rittger H, Bonaventura K, Zeymer U, Wohrle J, Jeger R, Levenson B, Mobius-Winkler S, Bruch L, Fischer D, Hengstenberg C, Porner T, Mathey D, Scheller B. Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol. 2013 Nov;102(11):785-97. doi: 10.1007/s00392-013-0609-7. Epub 2013 Aug 28.'}, {'pmid': '40204209', 'type': 'DERIVED', 'citation': 'Somsen YBO, de Winter RW, Wu J, Hoek R, Sprengers RW, Verouden NJ, Claessen BEPM, Kleijn SA, Twisk JWR, Henriques JP, Spratt JC, Rissanen TT, McEntegart MB, Maehara A, Nap A, Knaapen P. Design and rationale of the drug-coated balloon coronary angioplasty versus stenting for treatment of disease adjacent to a chronic total occlusion (Co-CTO) trial. Am Heart J. 2025 Oct;288:65-76. doi: 10.1016/j.ahj.2025.03.023. Epub 2025 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'This is an investigator-initiated, randomized, multi-center, non-inferiority clinical trial. Patients with a Chronic Total Occlusion who are eligible for PCI will be randomized to additional Drug-Coated-Balloon treatment or stenting of adjacent residual disease to the CTO body. The aim of this study is to investigate whether treatment with DCB is non-inferior to complete stenting of the CTO body.', 'detailedDescription': 'Rationale: Chronic total coronary occlusions (CTOs) are documented in approximately 16-18% of diagnostic coronary angiograms. New developments such as retrograde approach and dissection re-entry techniques have resulted in more widespread application of percutaneous coronary intervention (PCI) of CTOs, and this technique now serves as a viable alternative to optimal medical therapy alone or coronary artery bypass surgery. In general, PCI CTO is accompanied by extensive stenting of the coronary artery beyond the original occlusive segment itself. Unfortunately, stent length and diameter are directly related to poorer outcome, which is related to an increased rate of in-stent restenosis and thrombosis. An alternative to stenting is the application of drug-coated balloons (DCB). This strategy may prove beneficial, as it could significantly reduce stent length, among other things. However, data on the use of DCBs in the context of PCI CTO are currently lacking.\n\nObjective: To investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.\n\nStudy design: This is an investigator-initiated, randomized, single-blind (patients will be masked), multicenter, non-inferiority clinical trial.\n\nStudy population: 154 patients with a CTO eligible for PCI based on a formal local heart team decision will be screened for potential inclusion in the study.\n\nIntervention: Patients with a CTO who are eligible for PCI will be randomized in a 1:1 ratio to additional DCB treatment or stenting of residual disease.\n\nMain study parameters/endpoints: The primary endpoint is percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS). Secondary invasive imaging objectives include minimal lumen diameter, late luminal loss, in-segment binary restenosis, and target vessel re-occlusion at 1-year follow-up. Secondary clinical objectives are evaluation of the occurrence of major adverse cardiac events (MACE) at 1-year follow-up.\n\nNature and extent of the burden and risks associated with participation, benefit and group-relatedness: Participation in this study entails additional measurements, namely follow-up coronary angiography at 12 months, CCTA-scan at 12 months (if participating in substudy), and telephonic follow-up at 30 days and 12 months.\n\nAll patients included in the trial will have a clinical indication for percutaneous revascularization. Since there are no randomized controlled trials which advocate the use of either DES or DCB over one another in this setting, the risk of the PCI procedure will not be related to study participation. All patients will undergo coronary angiography after 1-year follow-up and will thus be exposed to the risks of invasive coronary angiography. Coronary angiography is characterized by a low complication rate (\\<0.5%). Repeat angiography also carries a low amount of radiation exposure. Patients participating in the CCTA substudy will be exposed to additional radiation. The ionized contrast agents used in both coronary angiography and CCTA substudy can be nephrotoxic and can elicit allergic reactions.\n\nA DCB facilitated minimal stenting strategy for treatment of chronic total occlusions may significantly reduce stent length, number of used stents, as well as compression of the distal lumen with undersized stents. While DCB is expected to be non-inferior to DES regarding the in-segment diameter stenosis (primary endpoint), possible benefits may be observed in the secondary endpoints. Consequently, this trial could influence current guidelines on the application of DCBs in CTO procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for revascularization of the CTO as determined by the local heart team (based on symptoms, documented ischemia, and viability)\n* Successful recanalization of the CTO with residual disease adjacent to the initial lesion\n\nExclusion Criteria:\n\n* Dissection affecting the flow (TIMI score\\<3), significant recoil (\\>30%) or coronary perforation after predilation\n* Reference diameter of the vessel is \\<2.5 mm or \\>4.0 mm\n* Bifurcation lesion requiring the stenting of the side branch\n* Left main lesion\n* Acute coronary syndrome\n* Cardiogenic shock\n* Severe kidney disease defined as an eGFR \\< 30 ml/min\n* Pregnancy\n* Life expectancy \\< 12 months\n* Inability to give written consent'}, 'identificationModule': {'nctId': 'NCT04881812', 'acronym': 'Co-CTO', 'briefTitle': 'Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'A Randomized, Multi-center, Non-inferiority Clinical Trial on the Treatment of Residual Disease With Drug-Coated Balloon After Successful Recanalization and Limiting Stenting to the CTO Body Compared to Complete Stenting of the CTO Body and Adjacent Residual Disease.', 'orgStudyIdInfo': {'id': 'VUmc_2020.0679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-coated balloon', 'description': 'Patients will receive stenting of the actual CTO body with additional DCB treatment of the residual disease of the coronary artery.', 'interventionNames': ['Device: Drug-Coated Balloons']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug-eluting stent', 'description': 'Patients will receive complete stenting of the CTO body and residual disease of the coronary artery.', 'interventionNames': ['Device: Drug-Eluting-Stent']}], 'interventions': [{'name': 'Drug-Coated Balloons', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).', 'armGroupLabels': ['Drug-coated balloon']}, {'name': 'Drug-Eluting-Stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).', 'armGroupLabels': ['Drug-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Yvemarie Somsen, MD', 'role': 'CONTACT', 'email': 'y.somsen@amsterdamumc.nl', 'phone': '+312 (0)444 3272'}, {'name': 'Paul Knaapen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Yvemarie Somsen, MD', 'role': 'CONTACT', 'email': 'y.somsen@amsterdamumc.nl', 'phone': '+312 (0)444 3272'}, {'name': 'Paul Knaapen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Yvemarie Somsen, MD', 'role': 'CONTACT', 'email': 'y.somsen@amsterdamumc.nl', 'phone': '+312 (0)444 3272'}], 'overallOfficials': [{'name': 'Paul Knaapen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor of Interventional Cardiology', 'investigatorFullName': 'Paul Knaapen', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}