Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-25 @ 3:00 PM
Study NCT ID:
NCT03939468
Status:
UNKNOWN
Last Update Posted:
2021-01-19
First Post:
2019-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DOCE at 12 Months', 'timeFrame': '12 Months', 'description': 'A device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the DCB-treated segment within 12 months after the index procedure'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'At procedure', 'description': 'Procedural success defined as both DCB/DES delivery and implantation at the "target" lesion site with \\<30% diameter stenosis (DS) in the DCB-treated segment and \\<10% DS in the DES-treated segment and distal TIMI 3 flow.'}, {'measure': 'Peri-procedural myocardial infarction', 'timeFrame': 'Pre-discharge', 'description': 'Peri-procedural myocardial infarction defined as an elevation of cardiac biomarkers (troponin or creatine kinase-myocardial band) \\>3 times the upper limit of normal'}, {'measure': 'DOCE', 'timeFrame': 'Pre-discharge, 30 days, 6 months, 12 months', 'description': 'DOCE and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR ) in-hospital, (within 7 days after PCI) and at 30-day, 6-month, 1-year follow-up'}, {'measure': 'Thrombosis', 'timeFrame': '12 months', 'description': 'Any definite/probable DES- or DCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 6month, 1-year follow-up).'}, {'measure': 'Flow-limiting dissection', 'timeFrame': '12 months', 'description': 'Flow-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Coated Balloons', 'Drug Eluting Stent', 'Diffuse Disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '24262615', 'type': 'BACKGROUND', 'citation': 'Costopoulos C, Latib A, Naganuma T, Sticchi A, Figini F, Basavarajaiah S, Carlino M, Chieffo A, Montorfano M, Naim C, Kawaguchi M, Giannini F, Colombo A. The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease. JACC Cardiovasc Interv. 2013 Nov;6(11):1153-9. doi: 10.1016/j.jcin.2013.07.005.'}, {'pmid': '27056119', 'type': 'BACKGROUND', 'citation': 'Ielasi A, Miyazaki T, Geraci S, Testa L, Abdel-Wahab M, Kawamoto H, Ruparelia N, Sato T, Caramanno G, Bedogni F, Tespili M, Colombo A, Latib A. Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: the "no more metallic cages" multicentre pilot experience. EuroIntervention. 2016 Apr 8;11(14):e1589-95. doi: 10.4244/EIJV11I14A309.'}, {'pmid': '30522667', 'type': 'BACKGROUND', 'citation': 'Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.'}, {'pmid': '32933874', 'type': 'BACKGROUND', 'citation': 'Ielasi A, Buono A, Pellicano M, Tedeschi D, Loffi M, Donahue M, Regazzoli D, De Angelis G, Danzi G, Reimers B, Tespili M. A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study. Cardiovasc Revasc Med. 2021 Jul;28:14-19. doi: 10.1016/j.carrev.2020.07.036. Epub 2020 Jul 31.'}, {'pmid': '37705369', 'type': 'DERIVED', 'citation': 'Buono A, Pellicano M, Regazzoli D, Donahue M, Tedeschi D, Loffi M, Zimbardo G, Reimers B, Danzi G, DE Blasio G, Tespili M, Ielasi A. Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study. Minerva Cardiol Angiol. 2024 Apr;72(2):163-171. doi: 10.23736/S2724-5683.23.06352-4. Epub 2023 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions', 'detailedDescription': 'This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator\'s discretion) for the treatment of diffuse CAD encountered in daily clinical practice. The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable or unstable CAD eligible for PCI (according to International guidelines) due to diffuse disease (located in the same vessel) suitable for a "hybrid approach" (see below) will be enrolled after signing the informed consent. A hybrid strategy was defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease (located in the smaller distal segment or at a side branch of a bifurcation in the same coronary artery). Diffuse disease is defined as CAD≥28 mm in length involving distal segments or side branches of a bifurcation lesion with a reference vessel diameter (RVD) considered suitable for a hybrid approach in case of ≥2.75 mm RVD for a DEStarget segment and ≥2.0 mm to \\<2.75 mm RVD for a DCB-target segment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse CAD involving segments suitable for a hybrid approach;\n* Signed Patient Informed Consent/Data Release Form\n\nExclusion Criteria:\n\n1. Age \\<18 years;\n2. Cardiogenic shock;\n3. Pregnancy or breastfeeding;\n4. Infarct-artery max diameter (within planned device deployment segment) \\<2.0 or \\>5.0 mm;\n5. Comorbidities with life expectancy \\<6 months;\n6. Severe calcification or/tortuosity proximally or at the DCB target segment;'}, 'identificationModule': {'nctId': 'NCT03939468', 'acronym': 'HYPER', 'briefTitle': 'Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'A HYbrid APproach Evaluating A DRug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'HYPER v3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Cohort', 'description': 'Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)', 'interventionNames': ['Device: DES+DCB']}], 'interventions': [{'name': 'DES+DCB', 'type': 'DEVICE', 'description': 'A hybrid strategy is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease', 'armGroupLabels': ['Observational Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rho', 'state': 'Milano', 'country': 'Italy', 'facility': 'Presidio Ospedaliero di Rho', 'geoPoint': {'lat': 45.53245, 'lon': 9.0402}}, {'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Istituto Clinico S.Anna', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cremona', 'country': 'Italy', 'facility': 'ASST Ospedale Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico S.Ambrogio', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Casilino', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ALFONSO IELASI', 'investigatorAffiliation': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}}}}