Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-28 @ 6:47 PM
Study NCT ID:
NCT06866756
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 479}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesions revascularization', 'timeFrame': '5 years', 'description': 'Rate of clinically driven target lesion revascularization (TLR) at 12 months, defined as any repeat percutaneous intervention or surgical bypass of the target lesion due to symptoms or objective evidence of ischemia'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '5 years', 'description': 'Incidence of Major Adverse Cardiovascular Events (MACE) at 5 years, defined as a composite of cardiovascular death, non-fatal myocardial infarction, and clinically driven lesion revascularization. Each event will be independently adjudicated by a clinical events committee.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DCB', 'Drug Coated Balloon', 'Drug eluting balloon', 'percutaneous coronary intervention', 'PCI'], 'conditions': ['Coronary Arterial Disease (CAD)']}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with a significant burden in low- and middle-income countries. Acute coronary syndrome (ACS) is often the first clinical manifestation of CVD, representing a major cause of morbidity and mortality. Global variations exist in revascularization rates and long-term mortality following ACS. It is estimated that 12% of disability-adjusted life years are lost annually due to CVD. Drug-coated balloons (DCB) constitute a promising technology to overcome few disadvantages of current latest generation of drug-eluting stents (DES). The safety of these devices has been proven previously. However, there is few data regarding its efficacy in a broad spectrum of clinical setting and patient population.\n\nHypothesis:\n\nThe sirolimus-coated drug-eluting balloon demonstrates comparable safety and efficacy to the paclitaxel-coated balloon in patients undergoing angioplasty for coronary artery disease.\n\nPrimary Objective:\n\nTo assess the safety and efficacy of paclitaxel- vs. sirolimus-coated drug-eluting balloon over 12 months in patients undergoing coronary angioplasty for in-stent restenosis or small-vessel stenosis.\n\nSecondary Objectives:\n\nTo compare the efficacy (freedom from target vessel failure) of both balloons at 12 months.\n\nTo evaluate the safety of paclitaxel- vs. sirolimus-coated balloon in coronary revascularization at 12 months.\n\nStudy Design:\n\nStudy Type: Prospective, single-center, analytical cohort study.\n\nPopulation: Patients undergoing angioplasty with paclitaxel- or sirolimus-coated drug-eluting balloons according to standard clinical practice.\n\nInclusion Criteria: Patients with De novo lesion and in stent reestenosis.\n\nStudy Period: From September 2021 to September 2026 or until the required sample size is achieved.\n\nStudy Importance:\n\nThis study will provide comparative evidence on the use of paclitaxel- and sirolimus-coated DCBs in coronary revascularization. The findings may contribute to future clinical recommendations for the optimal use of DCBs in patients with coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with coronary artery disease eligible for percutaneous coronary intervention with a balloon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with De novo lesion and in stent reestenosis.\n\nExclusion Criteria:\n\n* The patient is not a candidate for balloon treatment.'}, 'identificationModule': {'nctId': 'NCT06866756', 'briefTitle': 'Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon', 'organization': {'class': 'OTHER', 'fullName': 'Fundacin Biomedica Galicia Sur'}, 'officialTitle': 'Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon', 'orgStudyIdInfo': {'id': 'CAR-BAL-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sirolimus-Coated Balloon', 'description': 'Patients with coronary artery disease treated with Sirolimus-Coated Balloon'}, {'label': 'Paclitaxel-Coated Balloon', 'description': 'Patients with coronary artery disease treated with Paclitaxel-Coated Balloon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36312', 'city': 'Vigo', 'state': 'Pontevedra', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Víctor A Jiménez Díaz, MD, MPH', 'role': 'CONTACT', 'email': 'victor.alfonso.jimenez.diaz@sergas.es', 'phone': '+34986825564'}, {'name': 'Andres Iñiguez Romo, MD, PhD', 'role': 'CONTACT', 'email': 'andres.iniguez.romo@sergas.es', 'phone': '+34986825564'}, {'name': 'Victor A Jimenez Diaz, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'centralContacts': [{'name': 'Víctor A Jiménez DÍaz, MD, MPH', 'role': 'CONTACT', 'email': 'victor.alfonso.jimenez.diaz@sergas.es', 'phone': '+34986825564'}, {'name': 'Andrés Iñiguez Romo, MD, PhD', 'role': 'CONTACT', 'email': 'andres.iniguez.romo@sergas.es', 'phone': '+34986825564'}], 'overallOfficials': [{'name': 'Victor A Jimenez Diaz, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Servicio Galego de Saude. Hospital Álvaro Cunqueiro'}, {'name': 'Andres Iñiguez Romo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Servicio Galego de Saude. Hospital Álvaro Cunqueiro'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Deidentified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results and for a period of 5 years. Availability beyond this period will be considered upon request.', 'ipdSharing': 'YES', 'description': 'The data used to support the findings of this study are available from the corresponding author upon reasonable request.', 'accessCriteria': 'Qualified researchers may request access to the deidentified IPD and supporting information for scientifically sound proposals. Access will be granted after approval by the principal investigator and the signing of a data use agreement. Data will be shared via secure transfer.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andres Iñiguez Romo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology Department', 'investigatorFullName': 'Andres Iñiguez Romo', 'investigatorAffiliation': 'Fundacin Biomedica Galicia Sur'}}}}