An observational study in Coronary Artery Disease, Coronary Stenosis and Coronary Restenosis, sponsored by Fondazione Ricerca e Innovazione Cardiovascolare ETS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Fondazione Ricerca e Innovazione Cardiovascolare ETS · Observational
To characterize, using paired coronary computed tomography angiography (CCTA), longitudinal changes in coronary atherosclerotic plaque, lumen dimensions, and vessel remodeling between baseline and mid-term follow-up in de novo coronary lesions successfully treated with drug-coated balloon (DCB)-only angioplasty. No additional imaging examination, intervention, or clinical visit is mandated by the study protocol.
PICCOLETO XIII REVEAL-DCB Cohort A is an investigator-initiated, retrospective, international, multicenter observational cohort study evaluating CCTA-derived plaque and vessel changes after DCB-only percutaneous coronary intervention (PCI) for de novo coronary lesions.
Drug-coated balloons have become an established option within the contemporary PCI armamentarium, in line with the "leave nothing behind" treatment strategy. By delivering an antiproliferative agent directly to the vessel wall without permanent implantation of a metallic scaffold, DCB aim to limit neointimal proliferation while promoting positive vessel remodeling, preserving native vessel physiology and the option for future revascularization.
Serial angiographic and intracoronary imaging studies have described late lumen enlargement after DCB angioplasty, suggesting that the biological response to DCB treatment extends beyond the prevention of restenosis. However, the mechanisms underlying this phenomenon, and in particular the longitudinal changes in atherosclerotic plaque burden and composition after DCB treatment, remain incompletely characterized.
CCTA provides a unique opportunity to investigate these processes noninvasively. Beyond assessment of luminal stenosis, contemporary CCTA allows quantitative characterization of vessel dimensions, total and component-specific plaque volumes and plaque burden, assessment of plaque phenotypes and high-risk plaque features, assessment of plaque remodeling and of changes in plaque composition during follow-up, and pre-procedural CCTA-assisted DCB angioplasty. Importantly, the absence of a permanent metallic scaffold after DCB-only PCI avoids stent-related blooming and beam-hardening artifacts, allowing direct serial assessment of both the coronary lumen and the vessel wall within the treated segment.
Consecutive patients undergoing successful DCB-only PCI for a de novo coronary lesion will be identified from participating centers. Eligible patients will have either a diagnostic-quality CCTA performed before the index PCI and/or a diagnostic-quality follow-up CCTA performed within 12 months (minimum 3 months). If available, baseline and follow-up CCTA examinations will be anatomically matched at the lesion level to enable paired quantitative assessment of the same DCB-treated coronary segment over time. All imaging, procedural, and clinical data will derive from examinations and medical records obtained during routine clinical care.
Baseline and follow-up CCTA examinations will be analyzed using a standardized protocol by an expert and independent core laboratory. Whenever feasible, paired examinations will be evaluated using the same dedicated quantitative plaque-analysis software, with comparable reconstruction parameters, and analyses will be performed by investigators blinded to procedural strategy and clinical outcomes.
This is an exploratory, hypothesis-generating retrospective study which does not require sample sizing assumptions. Its first aim is to understand the current state of the art in order to develop prospective studies with rigorous protocols.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 200 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fondazione Ricerca e Innovazione Cardiovascolare ETS is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Adult patients with coronary artery disease who underwent successful DCB-only PCI for at least 1 de novo coronary lesion at participating centers, with either a diagnostic-quality CCTA performed before the index PCI and/or a diagnostic-quality follow-up CCTA performed within 12 months (minimum 3 months).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients who underwent successful drug-coated balloon-only PCI of at least 1 de novo coronary lesion, with a diagnostic-quality CCTA performed before the index PCI and/or a diagnostic-quality follow-up CCTA performed 3 to 12 months after DCB angioplasty, as part of routine clinical care.
Change in CCTA-Derived Total Coronary Plaque Volume (mm³)
Absolute change in total coronary plaque volume, expressed in cubic millimeters (mm³), within the DCB-treated coronary segment, calculated as follow-up total plaque volume minus baseline total plaque volume, as measured by an independent CCTA core laboratory.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Calcified Plaque Volume (mm³)
Absolute change in calcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline calcified plaque volume.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Binary Restenosis at Follow-up (≥50% Diameter Stenosis)
Number of DCB-treated lesions with ≥50% diameter stenosis on follow-up CCTA.
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Noncalcified Plaque Volume (mm³)
Absolute change in noncalcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline noncalcified plaque volume.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Low-Attenuation Plaque Volume (mm³)
Absolute change in low-attenuation plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline low-attenuation plaque volume.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in Calcified Plaque Volume as a Percentage of Total Plaque Volume (%)
Change in the proportion of calcified plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in Noncalcified Plaque Volume as a Percentage of Total Plaque Volume (%)
Change in the proportion of noncalcified plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in Low-Attenuation Plaque Volume as a Percentage of Total Plaque Volume (%)
Change in the proportion of low-attenuation plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Minimal Lumen Area (mm²)
Absolute change in minimal lumen area, expressed in mm², within the DCB-treated coronary segment, calculated as follow-up minus baseline minimal lumen area.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Vessel Remodeling Index
Absolute change in the vessel remodeling index, defined as the ratio of lesion-site vessel area to reference-segment vessel area (a dimensionless ratio), within the DCB-treated coronary segment, calculated as follow-up minus baseline remodeling index.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With a Change in Predominant Plaque Composition Category
Number of DCB-treated lesions in which the predominant plaque composition category (calcified, noncalcified, or mixed), assigned at baseline CCTA, differs from the category assigned at follow-up CCTA.
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Positive Remodeling at Follow-up
Number of DCB-treated lesions classified as showing positive remodeling on follow-up CCTA, per the remodeling index threshold prespecified in the study protocol.
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Low-Attenuation Plaque at Follow-up
Number of DCB-treated lesions with low-attenuation plaque identified on follow-up CCTA.
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Spotty Calcification at Follow-up
Number of DCB-treated lesions with spotty calcification identified on follow-up CCTA.
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Napkin-Ring Sign at Follow-up
Number of DCB-treated lesions with a napkin-ring sign identified on follow-up CCTA.
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Participants With Target Lesion Failure
Clinical Outcome Measure - Number of participants experiencing target lesion failure, defined as the composite of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization.
Time frame: 12 months.
Number of Participants With Any Myocardial Infarction (Target-Vessel or Non-Target-Vessel)
Clinical Outcome Measure - Number of participants experiencing myocardial infarction attributable to any coronary territory, target-vessel or non-target-vessel.
Time frame: 12 months.
Number of Participants With BARC Type ≥3 Major Bleeding
Clinical Outcome Measure - Number of participants experiencing Bleeding Academic Research Consortium (BARC) type ≥3 bleeding, as defined in the study protocol.
Time frame: 12 months.
Number of Participants With All-Cause Death
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants With Cardiac Death
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants With Target-Vessel Myocardial Infarction
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants With Clinically Driven Target Lesion Revascularization
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants With Clinically Driven Target Vessel Revascularization
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants Hospitalized for Unstable Angina
Clinical Outcome Measure.
Time frame: 12 months.
Number of Participants With Stroke
Clinical Outcome Measure.
Time frame: 12 months.
No study locations are listed for this record.
Plan to share: Undecided — Individual participant data may be made available to qualified researchers upon reasonable request after study completion and primary publication, subject to appropriate data use agreements, applicable data protection legislation, and ethics committee approval.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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