NCT07868523Not yet recruiting
The PICCOLETO XIII REVEAL-DCB Cohort A Study
REmodeling and pLaque Evolution After de Novo Coronary DCB Angioplasty: a Coronary Computed Tomography Angiography Study - The PICCOLETO XIII REVEAL-DCB Cohort A Study
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Jan 2027
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Diseases
- Coronary artery disease
- NCT number
- NCT07868523
What you commit to
- Study type: Observational
- Planned participants: 200
- From Oct 2026 to the primary completion date, Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Life expectancy less than 12 months from a non-cardiac cause
Other
- In-stent restenosis as the target lesion
- Bailout or planned stent implantation within the target segment during the index procedure
- CCTA of insufficient diagnostic quality for quantitative analysis of the target segment because of severe calcification, motion artifact, misregistration, or other technical limitations
- Follow-up CCTA performed outside the prespecified time window
- Target-lesion revascularization before the scheduled follow-up CCTA, precluding paired imaging assessment of the untreated follow-up state
- Inability to reliably identify and match the DCB-treated coronary segment between the index angiogram and baseline/follow-up CCTA
Who the study is looking for
- Age ≥18 years
- Presence of ≥1 de novo coronary lesion treated with successful DCB-only PCI
- No stent implantation within the target segment during the index procedure
- Diagnostic-quality CCTA performed before the index PCI and/or diagnostic-quality follow-up CCTA performed 3 to 12 months after DCB angioplasty
- Adequate visualization of the target vessel and treated segment on the available CCTA examination(s) to permit quantitative analysis
- Availability of the index PCI angiogram and sufficient procedural data to identify the DCB-treated segment
- Successful index PCI with an acceptable final angiographic result and stable clinical status at discharge
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.