NCT07391033Not yet recruiting
The PICCOLETO XI A-PREP Study
Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting/scoring/OPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Diseases
- Coronary artery disease
- NCT number
- NCT07391033
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Jun 2026 to the primary completion date, 1 Dec 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
- \- Lack of clinical outcome assessment
Who the study is looking for
- Adult patients ≥18 years of age
- Patients who underwent DCB angioplasty for in-stent restenosis
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.