Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07477405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], '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'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': '2 Years', 'description': 'Target Lesion Failure (TLF) defined as a composite of:\n\n1. Cardiac Death\n2. Target vessel Myocardial infarction (MI)\n3. Clinically driven target lesion revascularization (TLR)'}], 'secondaryOutcomes': [{'measure': 'Efficacy Endpoints', 'timeFrame': '30 days and 2 Years', 'description': '1. Target lesion revascularization (TLR)\n2. Target vessel revascularization (TVR)'}, {'measure': 'Safety Endpoints', 'timeFrame': '2 Years', 'description': '1. Major Adverse Cardiovascular Events (MACE) defined as a composite of :\n\n 1. All-cause mortality\n 2. MI (target-vessel and non-target-vessel MI)\n 3. Clinically driven TLR\n2. All-cause mortality\n3. Cardiovascular mortality\n4. Myocardial infarction\n5. Stroke (ischemic or haemorrhagic)\n6. Acute kidney injury (AKI)\n7. Major bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-coated balloons', 'Percutaneous Coronary Intervention', 'DEB', 'PCI'], 'conditions': ['Coronary Artery Disease (CAD)', 'ST-elevation Myocardial Infarction (STEMI)']}, 'descriptionModule': {'briefSummary': 'Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of intimal hyperplasia, a characteristic phenomenon of bare metal stents (BMS).\n\nDES have shown to be safe and effective in many clinical and anatomical scenarios. There are, however, several caveats to DES, like restenosis, thrombosis, accelerated atherosclerosis, impossibility of surgical revascularization and disruption of vessel dynamics.\n\nThese phenomena have a very meaningful negative impact on patient outcomes. Drug-coated balloons (DCB) may avoid those limitations of DES and are an appealing alternative in many different scenarios. They have been the mainstay treatment of in-stent restenosis (ISR) and were formally recommended for this setting in internationally, although recent guidelines recommend DES over a DCB for a first DES restenosis. There is, however, solid evidence for their use in the context of any ISR (BMS or DES-related) and both comparing with POBA or DES. The presence of metal from previous stents makes the implantation of more stents even more of a thing to avoid.\n\nHigh bleeding risk may also be an advantageous setting for DCB, as it may allow for a shorter or less intensive anti-thrombotic treatment with the same or even improved safety endpoints when compared to BMS or DES with standard therapy.\n\nOther than ISR, there are other particularly appealing anatomical settings for DCBs such as bifurcations, small vessels and diffuse disease. In the setting of a bifurcation where only the side branch is to be treated, there is evidence that DCB is a good option and provides significantly less late luminal loss when compared to POBA. In case a stent is used in the main branch, a DCB is also a good option for the side branch.\n\nIn small vessels (\\<3,0mm), in which the stent metal would be more conspicuous relative to the smaller lumen, there is strong evidence pointing to a benefit of DCB when compared to balloon angioplasty (POBA) and results at least as good as full-DES. A similar MACE rate between DCB and DES has been reported, with a benefit for DCB in terms of bleeding. In fact, also in larger vessels, DCB may lead to similarly good outcomes. DCB (alone or in combination with DES) is a good alternative to DES-only in diffuse disease.\n\nProvided that a good lesion preparation is achieved and there is no structural compromise to the vessel, the lack of a metal stent will be of benefit for any type of lesion. It will contribute to late lumen enlargement (LLE), which can happen in 40-56% of lesions treated with DCB7 and is associated with layered plaques by OCT and medial dissection after lesion preparation.\n\nEvidence for DCBs is increasing in different anatomical and clinical contexts, and there are some dedicated recommendations and consensus regarding their use. There is some data regarding real-world clinical performance of DCBs, but there is still the need for large real-world studies with different DCBs, techniques, clinical settings and anatomical contexts with long term follow-up, which is the main driver for this registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing percutaneous coronary intervention (PCI) in which a drug-coated balloon (DCB) is used in at least one coronary lesion.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient over the age of 18 years, undergoing PCI with at least one DCB attempted.\n2. Patient has provided written informed consent as approved by the Ethics Committee (EC)\n3. Patient is willing to undergo all registry procedures and follow-up requirements\n\nExclusion Criteria:\n\n1. Patients with known allergy to antiplatelet drugs or DCB antiproliferative agents\n2. Life expectancy less than 12 months\n3. Cardiogenic shock\n4. Left ventricular ejection fraction \\< 15%.\n5. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the registry.'}, 'identificationModule': {'nctId': 'NCT07477405', 'acronym': 'DESPORT', 'briefTitle': 'Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal', 'organization': {'class': 'OTHER', 'fullName': 'Portuguese Association of Interventional Cardiology'}, 'officialTitle': 'Drug-coatEd Balloon Multicentric Registry in Spain and PORTugal', 'orgStudyIdInfo': {'id': 'DESPORT-1'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Neves, MD', 'role': 'CONTACT', 'email': 'dcneves25@hotmail.com', 'phone': '+351 217 970 685'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portuguese Association of Interventional Cardiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}