The PICCOLETO XI A-PREP Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥18 years of age
Patients who underwent DCB angioplasty for in-stent restenosis
Disqualifiers
None
Trial population
Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Aggressive Lesion Preparation
Group B: Standard Lesion Preparation
Trial outcomes
Primary outcomes
1
Major Adverse Cardiovascular Events (MACE)
Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).
Time frame
12 monthsSecondary outcomes
1
Cardiac Death
Death attributed to cardiovascular causes, including death from unknown cause.
Time frame
12 months and longest available follow-up2
Non-fatal Myocardial Infarction
Non-fatal myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction.
Time frame
12 months and longest available follow-up3
Target Lesion Revascularization (TLR)
Any repeat revascularization (percutaneous or surgical) of the target lesion.
Time frame
12 months and longest available follow-up4
Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria.
Time frame
12 months and longest available follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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