Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-27 @ 4:14 PM
Study NCT ID:
NCT05650450
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-08
First Post:
2022-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease
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': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLF in DES/DCB treated segment at 12 months', 'timeFrame': '12 months', 'description': 'Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (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 (Thrombolysis in Myocardial Infarction) 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': 'TLF', 'timeFrame': 'Pre-discharge, 30 days, 12 months, 24 months', 'description': 'TLF and its singular components (cardiac death, any TV-MI excluding peri-procedural MI, ID-TLR)'}, {'measure': 'Thrombosis', 'timeFrame': 'In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up', 'description': 'Any definite/probable DES- or DCB-treated segment thrombosis'}, {'measure': 'Flow-limiting dissection', 'timeFrame': 'At procedure', 'description': 'low-limiting dissection (type C-F waiting 3 minutes after DCB inflation) requiring additional DES implantation in the DCB-treated segment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'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': '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.'}]}, 'descriptionModule': {'briefSummary': 'An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease', 'detailedDescription': 'This is a prospective, non-randomized, single-arm, multi-center study aiming 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 (Coronary Artery Disease) encountered in daily clinical practice (lesion length \\> 38 mm). 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'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment). Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES in the larger, more proximal part of the vessel -reference vessel diameter -RVD \\>2.75 mm- and DCB inflation for a concomitant and contiguous de novo small vessel disease - distally located with RVD ≤2.75 mm ≥2.0 mm.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);\n* Signed Patient Informed Consent/Data Release Form\n\nExclusion Criteria:\n\n* Age \\<18 years;\n* Cardiogenic shock;\n* Pregnancy or breastfeeding;\n* Target vessel reference diameter (within planned device deployment segments) \\<2.0 or \\>5.0 mm;\n* Comorbidities with life expectancy \\<12 months\n* Severe calcification or/tortuosity proximally or at the DCB target segment;\n* Prior PCI and stent implantation in the target vessel.'}, 'identificationModule': {'nctId': 'NCT05650450', 'acronym': 'HYPER II', 'briefTitle': 'Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease', '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 Long Diffuse Coronary Artery Disease: The HYPER II Study', 'orgStudyIdInfo': {'id': 'HYPER II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)', 'interventionNames': ['Device: DES+DCB']}], 'interventions': [{'name': 'DES+DCB', 'type': 'DEVICE', 'description': 'Hybrid approach is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES for a de novo long (\\>38 mm) lesion (located in the larger, more proximal part of the vessel -reference vessel diameter -RVD \\>2.75 mm-) and DCB inflation for a concomitant and contiguous de novo small vessel disease (distally located with RVD ≤2.75 mm ≥ 2.0 mm)', 'armGroupLabels': ['Patient with diffuse CAD disease treated with hybrid strategy (DES+DCB)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico S.Ambrogio', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}