Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT05801003
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
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', 'interventionModelDescription': 'Prospective, multicenter, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2023-03-11', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum stent area post-stenting measured by optimal coherence tomography (OCT)', 'timeFrame': 'Immediately after the procedure'}], 'secondaryOutcomes': [{'measure': 'Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).', 'timeFrame': '9 month follow-up.', 'description': 'Key secondary'}, {'measure': 'Mean stent area measured by optimal coherence tomography', 'timeFrame': '9 month follow-up.'}, {'measure': 'Acute procedural success', 'timeFrame': 'Immediately after the procedure'}, {'measure': 'Coronary disection', 'timeFrame': 'Immediately after the procedure'}, {'measure': 'Malapposition (Major/minor) post-stenting measured by optimal coherence tomography', 'timeFrame': 'Immediately after the procedure and at 9 month follow-up'}, {'measure': 'Mean neointimal hyperplasia area measured by optimal coherence tomography', 'timeFrame': '9 months'}, {'measure': 'Minimum stent eccentricity measured by optimal coherence tomography', 'timeFrame': '9 months'}, {'measure': 'Stent asymmetry index measured by optimal coherence tomography', 'timeFrame': '9 months'}, {'measure': 'All cause death', 'timeFrame': '12 months'}, {'measure': 'Death from cardiovascular causes', 'timeFrame': '12 months'}, {'measure': 'Target vessel myocardial infarction', 'timeFrame': '12 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 months'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 months'}, {'measure': 'Any myocardial infarction', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Cutting Balloon']}, 'descriptionModule': {'briefSummary': 'Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.\n\nLesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions', 'detailedDescription': 'The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.\n\nA total of 96 patients with de novo coronary artery stenosis will be included.\n\nAfter being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:\n\nA) Study group: Pre-dilation with cutting balloon followed by ASES implantation.\n\nB) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.\n\nStent optimisation will be performed based on intracoronary imaging findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses \\>50% in a native coronary artery.\n\nExclusion Criteria:\n\n1. Cardiogenic shock\n2. Patients presenting with ST-segment elevation myocardial infarction\n3. Patients undergoing chronic total occlusions PCI\n4. Patients undergoing left main PCI\n5. Patients undergoing venous bypass graft lesions PCI\n6. Patients with in-stent restenosis\n7. Inability to provide informed consent\n8. Life expectancy \\<1year due to non-cardiac disease\n9. Currently participating in another trial before reaching first endpoint\n\nThere will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.'}, 'identificationModule': {'nctId': 'NCT05801003', 'acronym': 'CUT-DRESS', 'briefTitle': 'Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Fe'}, 'officialTitle': 'Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation', 'orgStudyIdInfo': {'id': '529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Pre-dilation with cutting balloon followed by ASES implantation.', 'interventionNames': ['Device: Predilation with cutting balloon.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.', 'interventionNames': ['Device: Predilation with conventional balloon']}], 'interventions': [{'name': 'Predilation with cutting balloon.', 'type': 'DEVICE', 'otherNames': ['Wolverine Cutting balloon'], 'description': 'PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.', 'armGroupLabels': ['Study group']}, {'name': 'Predilation with conventional balloon', 'type': 'DEVICE', 'description': 'PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Estefania Fernandez Peregrina', 'role': 'CONTACT'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Sanz Sanchez, MD, PhD', 'role': 'CONTACT', 'email': 'sjorge4@gmx.com', 'phone': '440087'}, {'name': 'Jose Luis Diez Gil, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Eva Rumiz González, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Cardiology, MD, PhD', 'investigatorFullName': 'Jorge Sanz Sanchez', 'investigatorAffiliation': 'Hospital Universitario La Fe'}}}}