Trial Radar AI | ||
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Clinical Trial NCT06915597 (DCB-DCS) for Coronary Arterial Disease (CAD) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Drug-Coated Coronary Balloons in Different Clinical Scenarios (DCB-DCS) 1,500
Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios
- DCB-DCS
coronary artery disease
chronic total occlusions
de novo lesions
small vessel disease
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Coronary artery disease Patients with coronary artery disease who were treated with drug coated balloons will be included in the study. | N/A |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Death, target lesion revascularization, target vessel revascularization, myocardial infarction | Cardiac or noncardiac death events will be recorded during follow up. Forthermore, target vessel or lesion revascularization, myocardial infarction will be recorded according to the previously described criteria. | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3) | Assessment of symptomatic angina status, need for repeat revascularization of the target vessel, procedural success including the requirement for bailout stent implantation, and the occurrence of major bleeding events defined as Bleeding Academic Research Consortium (BARC) type ≥3. | 12 months |
Age ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion.
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.
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.
Kutahya Health Sciences University- 🎓Pamukkale Univ...