Drug-Coated Coronary Balloons in Different Clinical Scenarios
NCT ID: NCT06915597
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2025-05-31
2026-05-31
Brief Summary
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Detailed Description
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Consecutive patients undergoing percutaneous coronary intervention (PCI) with a DCB-based strategy, either as a stand-alone therapy or in combination with bailout stenting, will be prospectively and retrospectively enrolled from participating high-volume centers. Detailed demographic, clinical, laboratory, angiographic, procedural, and pharmacological data will be systematically collected. Lesion characteristics will be classified according to standard angiographic and anatomical criteria, and procedural techniques including lesion preparation strategy (plain balloon, cutting/scoring balloon, high-pressure non-compliant balloon, atherectomy), use of intravascular imaging (IVUS, OCT, OFDI), and DCB type, size, and inflation protocol will be recorded.
The registry will assess short-term procedural success and long-term clinical outcomes, including major adverse cardiovascular events (MACE), target lesion failure, target vessel revascularization, myocardial infarction, stent thrombosis (when applicable), and all-cause and cardiovascular mortality. Subgroup analyses will explore the impact of different clinical presentations, lesion subsets, and procedural strategies on outcomes, with particular emphasis on the role of optimal lesion preparation, intravascular imaging guidance, and the need for bailout stenting.
By reflecting routine clinical practice in a large, unselected population, the DCB-DCS Registry seeks to define optimal procedural standards, identify predictors of success and failure, and generate hypothesis-forming data to guide future randomized controlled trials comparing DCB-based strategies with new-generation drug-eluting stents across diverse coronary scenarios.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Coronary artery disease
Patients with coronary artery disease who were treated with drug coated balloons will be included in the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
DCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes.
DCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions.
Successful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment).
Availability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion.
Planned clinical follow-up.
Exclusion Criteria
Cardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.
18 Years
ALL
No
Sponsors
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Kutahya Health Sciences University
OTHER
Pamukkale University
OTHER
Memorial Bahçelievler Hospital
OTHER
Bezmialem Vakif University
OTHER
Dicle University
OTHER
Ordu University
OTHER
Adana City Training and Research Hospital
OTHER
Marmara University
OTHER
Trakya University
OTHER
Kafkas University Health Research and Application Hospital
UNKNOWN
Selcuk University
OTHER
Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Fatih Kahraman
Associate Professor
Locations
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Pamukkale University
Denizli, , Turkey (Türkiye)
Bahcelievler Memorial Hospital
Istanbul, , Turkey (Türkiye)
Bezmialem Vakıf Universitesi
Istanbul, , Turkey (Türkiye)
Goztepe Medicalpark Hastanesi
Istanbul, , Turkey (Türkiye)
Kutahya City Hospital
Kütahya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DCB-DCS
Identifier Type: -
Identifier Source: org_study_id
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