Coronary Artery Disease, In-Stent Coronary Artery Restenosis
Conditions
Keywords
Drug-Coated Balloon, In-Stent Restenosis, Lesion Preparation, Cutting Balloon, Scoring Balloon, Percutaneous Coronary Intervention
Brief summary
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.
Detailed description
PICCOLETO XI A-PREP is an investigator-initiated, multicenter, international, observational study evaluating the impact of lesion preparation strategies on outcomes following drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). In-stent restenosis remains a clinically relevant challenge despite advances in drug-eluting stent technology and contemporary percutaneous coronary intervention techniques. DCB represents a stentless therapeutic strategy for ISR treatment, with the advantage of avoiding implantation of additional metallic layers. A key determinant of clinical outcomes in ISR, particularly with DCB angioplasty, is the adequacy of lesion preparation before definitive therapy. Effective preparation facilitates optimal drug delivery, improves luminal gain, and may reduce the risk of recurrent restenosis. A large spectrum of balloon-based modalities is available for ISR lesion preparation, ranging from semi-compliant and non-compliant balloons to more aggressive tools such as scoring and cutting balloons. Although more aggressive devices may enhance plaque modification and neointimal tissue disruption, their incremental clinical benefit over standard approaches remains uncertain. Patients will be categorized into two groups based on lesion preparation strategy: * Aggressive preparation: Cutting/Wolverine balloons, scoring balloons (any brand), and/or OPN balloons * Standard preparation: Semi-compliant balloons and/or non-compliant balloons Clinical outcomes will be assessed at 1-year and longest available follow-up.
Interventions
None listed
Sponsors
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years of age * Patients who underwent DCB angioplasty for in-stent restenosis
Exclusion criteria
\- Lack of clinical outcome assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 12 months | Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Dissection | At procedure | Presence and type of coronary dissection after lesion preparation and DCB treatment. |
| Cardiac Death | 12 months and longest available follow-up | Death attributed to cardiovascular causes, including death from unknown cause. |
| Non-fatal Myocardial Infarction | 12 months and longest available follow-up | Non-fatal myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction. |
| Target Lesion Revascularization (TLR) | 12 months and longest available follow-up | Any repeat revascularization (percutaneous or surgical) of the target lesion. |
| Target Vessel Myocardial Infarction (TV-MI) | 12 months and longest available follow-up | Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria. |
| BARC Major Bleeding | 12 months and longest available follow-up | Bleeding Academic Research Consortium (BARC) major bleeding events (type 3-5). |
| Procedural Success | At procedure | Successful DCB angioplasty with residual stenosis less than 30% and TIMI flow grade 3 without major procedural complications. |
| Post-procedural Diameter Stenosis | At procedure | Percentage of diameter stenosis after DCB angioplasty assessed by quantitative coronary angiography. |
| TIMI Flow Grade | At procedure | Thrombolysis In Myocardial Infarction (TIMI) flow grade assessment post-procedure. |
Contacts
CONTACTFilippo Luca Gurgoglione, MD, PhD
CONTACTBeatrice Barbano
PRINCIPAL_INVESTIGATORBharat Khialani, MD
Tan Tock Seng Hospital, National Healthcare Group, Singapore
PRINCIPAL_INVESTIGATORFilippo Luca Gurgoglione, MD, PhD
Department of Cardiology, Parma University Hospital, Parma, Italy
STUDY_CHAIRBernardo Cortese, MD
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Outcome results
None listed