Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06657833
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
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': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFFICACY: Late Lumen Loss (LLL)', 'timeFrame': '9 Month', 'description': 'Late lumen loss (LLL, expressed in mm) measured within the treated segment by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter (MLD) at the end of the interventional procedure and MLD at 6-month follow-up'}, {'measure': 'EFFICACY: Net Lumen Gain (NLG)', 'timeFrame': '9 Month', 'description': 'Net lumen gain (NLG, expressed in mm) measured by quantitative coronary angiography (QCA) as the difference between minimal luminal diameter within the treated segment (MLD) at 6-month follow-up and MLD at the lesion site at baseline'}], 'secondaryOutcomes': [{'measure': 'SAFETY: Dissection', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from dissection'}, {'measure': 'SAFETY: Perforation', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from perforation'}, {'measure': 'SAFETY: Abrupt vessel closure', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from abrupt vessel closure'}, {'measure': 'SAFETY: Slow Flow', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from slow flow'}, {'measure': 'SAFETY: No Reflow', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from no reflow'}, {'measure': 'SAFETY: Thrombosis', 'timeFrame': 'During Percutaneous Coronary Intervention (PCI)', 'description': 'Freedom from thrombosis'}, {'measure': 'SAFETY: MACE', 'timeFrame': 'Up to 30 days', 'description': 'Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.'}, {'measure': 'SAFETY: Stent Thrombosis', 'timeFrame': 'During hospitalization', 'description': 'Freedom Stent thrombosis'}, {'measure': 'SAFETY: Major bleeding event', 'timeFrame': 'During hospitalization', 'description': 'Freedom from Mayor bleeding event according to ≥ (BARC 3 criteria )'}, {'measure': 'SAFETY: Stent Thrombosis', 'timeFrame': 'During hospitalization', 'description': 'Freedom from stent thrombosis'}, {'measure': 'SAFETY: Hemodynamic stability', 'timeFrame': 'During hospitalization', 'description': 'Freedom for need for unplanned vasopressors/inotropes or ventricular support devices'}, {'measure': 'EFFICACY: Minimal Lumen Diameter (MLD)', 'timeFrame': 'Day 0', 'description': 'Change in MLD Immediately before procedure, immediately after procedure'}, {'measure': 'EFFICACY: Diameter Stenosis', 'timeFrame': 'Day 0', 'description': 'Percentaje of Diammeter Stenosis after PCI'}, {'measure': 'EFFICACY: Minimal Lumen Diameter (MLD)', 'timeFrame': '9 Months', 'description': 'Change in MLD during follow-up'}, {'measure': 'EFFICACY: Minimal Lumen Diammeter (MLD)', 'timeFrame': '12 Months', 'description': 'Change in MLD during follow-up'}, {'measure': 'EFFICACY: Binary reestenosis', 'timeFrame': '9 Months', 'description': 'Freedom from reestenosis by angiography during follow-up'}, {'measure': 'EFFICACY: Crossover rate', 'timeFrame': 'Day 0', 'description': 'Rate of stent change ( DEB to DES or DES to DEB) during follow-up'}, {'measure': 'SAFETY: MACE', 'timeFrame': '9 Months', 'description': 'Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.'}, {'measure': 'SAFETY: MACE', 'timeFrame': '12 Months', 'description': 'Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.'}, {'measure': 'SAFETY: MACE', 'timeFrame': '24 Months', 'description': 'Freedom of The composite of cardiac death, myocardial infarction (MI) and target lesion revascularization.'}, {'measure': 'SAFETY: Myocardial Infarction', 'timeFrame': '9 Months', 'description': 'Freedom from myocardial infarction'}, {'measure': 'SAFETY: Myocardial Infarction', 'timeFrame': '12 Months', 'description': 'Freedom from myocardial infarction'}, {'measure': 'SAFETY: Myocardial Infarction', 'timeFrame': '24 Months', 'description': 'Freedom from myocardial infarction'}, {'measure': 'SAFETY: Cardiac death', 'timeFrame': '12 Months', 'description': 'Freedom from cardiac death'}, {'measure': 'SAFETY: Cardiac death', 'timeFrame': '24 Months', 'description': 'Freedom from cardiac death'}, {'measure': 'SAFETY: Target Lesion Revascularization.', 'timeFrame': '9 Months', 'description': 'Freedom from TLR'}, {'measure': 'SAFETY: Target Lesion Revascularization.', 'timeFrame': '12 Months', 'description': 'Freedom from TLR'}, {'measure': 'SAFETY: Target Lesion Revascularization.', 'timeFrame': '24 Months', 'description': 'Freedom from TLR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcified Nodules', 'Calcified lesions', 'Drug eluting balloon', 'Drug eluting stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345'}, {'pmid': '32259392', 'type': 'BACKGROUND', 'citation': 'Morofuji T, Kuramitsu S, Shinozaki T, Jinnouchi H, Sonoda S, Domei T, Hyodo M, Shirai S, Ando K. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):10-19. doi: 10.1002/ccd.28896. Epub 2020 Apr 7.'}, {'pmid': '28797410', 'type': 'BACKGROUND', 'citation': 'Lee T, Mintz GS, Matsumura M, Zhang W, Cao Y, Usui E, Kanaji Y, Murai T, Yonetsu T, Kakuta T, Maehara A. Prevalence, Predictors, and Clinical Presentation of a Calcified Nodule as Assessed by Optical Coherence Tomography. JACC Cardiovasc Imaging. 2017 Aug;10(8):883-891. doi: 10.1016/j.jcmg.2017.05.013.'}, {'pmid': '37164599', 'type': 'BACKGROUND', 'citation': 'Sato T, Matsumura M, Yamamoto K, Shlofmitz E, Moses JW, Khalique OK, Thomas SV, Tsoulios A, Cohen DJ, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting. JACC Cardiovasc Interv. 2023 May 8;16(9):1024-1035. doi: 10.1016/j.jcin.2023.03.009.'}, {'pmid': '31553205', 'type': 'BACKGROUND', 'citation': 'Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.'}, {'pmid': '34527034', 'type': 'BACKGROUND', 'citation': 'Ho HH, Lee JH, Khoo DZL, Hpone KKS, Li KFC. Shockwave intravascular lithotripsy and drug-coated balloon angioplasty in calcified coronary arteries: preliminary experience in two cases. J Geriatr Cardiol. 2021 Aug 28;18(8):689-691. doi: 10.11909/j.issn.1671-5411.2021.08.009. No abstract available.'}, {'pmid': '32857188', 'type': 'BACKGROUND', 'citation': 'Iwasaki Y, Koike J, Ko T, Funatsu A, Kobayashi T, Ikeda T, Nakamura S. Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels. Heart Vessels. 2021 Feb;36(2):189-199. doi: 10.1007/s00380-020-01684-z. Epub 2020 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).', 'detailedDescription': 'Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all inclusion criteria:\n\n* Patients \\>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and\n* Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;\n* Lesion to treat in a vessel between 2.5 and 4 mm.\n\nExclusion Criteria:\n\nPatients must not meet any criteria\n\n* Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.\n* Pregnant or breastfeeding patients.\n* Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.\n* Impossibility to maintain double antiplatelet treatment during at least 1 month.\n* Life expectancy \\<1 year.\n* Index lesion at left main stem.\n* Aorto-ostial lesion.\n* Target lesion previously treated with stents or DEB.\n* High thrombus burden in the target lesion (TIMI thrombus scale≥3).'}, 'identificationModule': {'nctId': 'NCT06657833', 'acronym': 'DEBSCAN-IVL', 'briefTitle': 'DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.', 'orgStudyIdInfo': {'id': 'EPIC40-DEBSCAN-IVL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Drug Eluting Balloon (DEB)', 'interventionNames': ['Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon']}, {'type': 'OTHER', 'label': 'Drug Eluting Stent (DES)', 'interventionNames': ['Device: Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent']}], 'interventions': [{'name': 'Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon', 'armGroupLabels': ['Drug Eluting Balloon (DEB)']}, {'name': 'Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent', 'armGroupLabels': ['Drug Eluting Stent (DES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Fuencarral-El Pardo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de La Paz', 'geoPoint': {'lat': 40.4984, 'lon': -3.7314}}, {'zip': '48960', 'city': 'Galdakao', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Galdakao-Usansolo', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '24008', 'city': 'León', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46014', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '36312', 'city': 'Vigo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'centralContacts': [{'name': 'FUNDACION EPIC', 'role': 'CONTACT', 'email': 'iepic@fundacionepic.org', 'phone': '0034987225638'}, {'name': 'ALFONSO JURADO ROMAN, MD,PhD', 'role': 'CONTACT', 'email': 'alfonsojuradoroman@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}