Coronary Artery DiseaseREVEAL-DCB-ANCT07868523
The PICCOLETO XIII REVEAL-DCB Cohort A Study
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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
- Life expectancy less than 12 months from a non-cardiac cause
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REmodeling and pLaque Evolution After de Novo Coronary DCB Angioplasty: a Coronary Computed Tomography Angiography Study - The PICCOLETO XIII REVEAL-DCB Cohort A Study
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Coronary Atherosclerosis, Vascular Remodeling
- Keywords
- Drug-Coated Balloon, Coronary Computed Tomography Angiography, De Novo Coronary Lesion, Plaque Volume, Plaque Composition, Vessel Remodeling, Late Lumen Enlargement, Percutaneous Coronary Intervention, CAD-RADS
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Vascular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DCB-only PCI cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernardo Cortese, MD, Study chair, Fondazione Ricerca e Innovazione Cardiovascolare ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868523
- Sponsor's protocol ID
- PICCOLETO XIII
- Acronym
- REVEAL-DCB-A
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Lazar FL, Onea HL, Olinic DM, Cortese B. A 2024 scientific update on the clinical performance of drug-coated balloons. AsiaIntervention. 2024 Feb 29;10(1):15-25. doi: 10.4244/AIJ-D-23-00010. eCollection 2024 Feb.
PubMed 38425817Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. Eur Heart J. 2025 Jul 7;46(26):2498-2519. doi: 10.1093/eurheartj/ehaf029.
PubMed 40270117Yamamoto M, Hara H, Kubota S, Hiroi Y. Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions. EuroIntervention. 2024 May 10;20(9):602-612. doi: 10.4244/EIJ-D-23-00849.
PubMed 38726721Serruys PW, Hara H, Garg S, Kawashima H, Norgaard BL, Dweck MR, Bax JJ, Knuuti J, Nieman K, Leipsic JA, Mushtaq S, Andreini D, Onuma Y. Coronary Computed Tomographic Angiography for Complete Assessment of Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Aug 17;78(7):713-736. doi: 10.1016/j.jacc.2021.06.019.
PubMed 34384554Nieman K, Garcia-Garcia HM, Hideo-Kajita A, Collet C, Dey D, Pugliese F, Weissman G, Tijssen JGP, Leipsic J, Opolski MP, Ferencik M, Lu MT, Williams MC, Bruining N, Blanco PJ, Maurovich-Horvat P, Achenbach S. Standards for quantitative assessments by coronary computed tomography angiography (CCTA): An expert consensus document of the society of cardiovascular computed tomography (SCCT). J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):429-443. doi: 10.1016/j.jcct.2024.05.232. Epub 2024 Jun 6.
PubMed 38849237Cury RC, Leipsic J, Abbara S, Achenbach S, Berman D, Bittencourt M, Budoff M, Chinnaiyan K, Choi AD, Ghoshhajra B, Jacobs J, Koweek L, Lesser J, Maroules C, Rubin GD, Rybicki FJ, Shaw LJ, Williams MC, Williamson E, White CS, Villines TC, Blankstein R. CAD-RADS 2.0 - 2022 Coronary Artery Disease-Reporting and Data System: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI). JACC Cardiovasc Imaging. 2022 Nov;15(11):1974-2001. doi: 10.1016/j.jcmg.2022.07.002. Epub 2022 Sep 14.
PubMed 36115815
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmodeling and pLaque Evolution After de Novo Coronary DCB Angioplasty: a Coronary Computed Tomography Angiography Study - The PICCOLETO XIII REVEAL-DCB Cohort A Study
- ClinicalTrials.gov ID
- NCT07868523
- Acronym / sponsor ID
- REVEAL-DCB-A / PICCOLETO XIII
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis, Coronary Atherosclerosis, Vascular Remodeling
- Keywords
- Drug-Coated Balloon, Coronary Computed Tomography Angiography, De Novo Coronary Lesion, Plaque Volume, Plaque Composition, Vessel Remodeling, Late Lumen Enlargement, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETSUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB-only PCI cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in CCTA-Derived Total Coronary Plaque Volume (mm³)
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
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.
14 secondary outcomes
Change in CCTA-Derived Calcified Plaque Volume (mm³)
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)
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Noncalcified Plaque Volume (mm³)
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Low-Attenuation Plaque Volume (mm³)
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 (%)
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 (%)
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 (%)
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Minimal Lumen Area (mm²)
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Change in CCTA-Derived Vessel 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
Time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Positive Remodeling at Follow-up
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Low-Attenuation Plaque at Follow-up
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Spotty Calcification at Follow-up
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Number of Lesions With Napkin-Ring Sign at Follow-up
Time frame: Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 38425817Lazar FL, Onea HL, Olinic DM, Cortese B. A 2024 scientific update on the clinical performance of drug-coated balloons. AsiaIntervention. 2024 Feb 29;10(1):15-25. doi: 10.4244/AIJ-D-23-00010. eCollection 2024 Feb.
- Background: PubMed 40270117Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. Eur Heart J. 2025 Jul 7;46(26):2498-2519. doi: 10.1093/eurheartj/ehaf029.
- Background: PubMed 38726721Yamamoto M, Hara H, Kubota S, Hiroi Y. Predictors of late lumen enlargement after drug-coated balloon angioplasty for de novo coronary lesions. EuroIntervention. 2024 May 10;20(9):602-612. doi: 10.4244/EIJ-D-23-00849.
- Background: PubMed 34384554Serruys PW, Hara H, Garg S, Kawashima H, Norgaard BL, Dweck MR, Bax JJ, Knuuti J, Nieman K, Leipsic JA, Mushtaq S, Andreini D, Onuma Y. Coronary Computed Tomographic Angiography for Complete Assessment of Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Aug 17;78(7):713-736. doi: 10.1016/j.jacc.2021.06.019.
- Background: PubMed 38849237Nieman K, Garcia-Garcia HM, Hideo-Kajita A, Collet C, Dey D, Pugliese F, Weissman G, Tijssen JGP, Leipsic J, Opolski MP, Ferencik M, Lu MT, Williams MC, Bruining N, Blanco PJ, Maurovich-Horvat P, Achenbach S. Standards for quantitative assessments by coronary computed tomography angiography (CCTA): An expert consensus document of the society of cardiovascular computed tomography (SCCT). J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):429-443. doi: 10.1016/j.jcct.2024.05.232. Epub 2024 Jun 6.
- Background: PubMed 36115815Cury RC, Leipsic J, Abbara S, Achenbach S, Berman D, Bittencourt M, Budoff M, Chinnaiyan K, Choi AD, Ghoshhajra B, Jacobs J, Koweek L, Lesser J, Maroules C, Rubin GD, Rybicki FJ, Shaw LJ, Williams MC, Williamson E, White CS, Villines TC, Blankstein R. CAD-RADS 2.0 - 2022 Coronary Artery Disease-Reporting and Data System: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI). JACC Cardiovasc Imaging. 2022 Nov;15(11):1974-2001. doi: 10.1016/j.jcmg.2022.07.002. Epub 2022 Sep 14.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernardo Cortese, MD study chair
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatrice Barbano (+39 329 876 8658, segreteria@fondazioneric.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CCTA-Derived Total Coronary Plaque Volume (mm³) (time frame: Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868523, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.