The PICCOLETO XIII REVEAL-DCB Cohort A Study

NCT07868523 | Not Yet Recruiting

• 1 other identifier: PICCOLETO XIII
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. No additional imaging examination, intervention, or clinical visit is mandated by the study protocol.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.

Secondary Outcomes (14)

• Change in CCTA-Derived Calcified Plaque Volume (mm³)

  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)

  Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.

• Change in CCTA-Derived Noncalcified Plaque Volume (mm³)

  Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.

• Change in CCTA-Derived Low-Attenuation Plaque Volume (mm³)

  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 (%)

  Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.

Other Outcomes (10)

• Number of Participants With Target Lesion Failure

  12 months.

• Number of Participants With Any Myocardial Infarction (Target-Vessel or Non-Target-Vessel)

  12 months.

• Number of Participants With BARC Type ≥3 Major Bleeding

  12 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Ricerca e Innovazione Cardiovascolare ETS: lead

Related Publications (6)

• 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.

  PMID: 38425817 BACKGROUND

• Fezzi 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.

  PMID: 40270117 BACKGROUND

• Yamamoto 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.

  PMID: 38726721 BACKGROUND

• Serruys 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.

  PMID: 34384554 BACKGROUND

• Nieman 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.

  PMID: 38849237 BACKGROUND

• Cury 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.

  PMID: 36115815 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis; Vascular Remodeling

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Bernardo Cortese, MD

  Fondazione Ricerca e Innovazione Cardiovascolare ETS

  STUDY CHAIR

Central Study Contacts

Beatrice Barbano

CONTACT

+39 329 876 8658; segreteria@fondazioneric.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10