The PICCOLETO XI A-PREP Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: In-Stent Coronary Artery Restenosis, Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study
Overview
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.
Primary outcome measures
- Major Adverse Cardiovascular Events (MACE) [Time frame: 12 months]
Secondary outcome measures (9)
- Cardiac Death [Time frame: 12 months and longest available follow-up]
- Non-fatal Myocardial Infarction [Time frame: 12 months and longest available follow-up]
- Target Lesion Revascularization (TLR) [Time frame: 12 months and longest available follow-up]
- Target Vessel Myocardial Infarction (TV-MI) [Time frame: 12 months and longest available follow-up]
- BARC Major Bleeding [Time frame: 12 months and longest available follow-up]
- Procedural Success [Time frame: At procedure]
- Post-procedural Diameter Stenosis [Time frame: At procedure]
- Angiographic Dissection [Time frame: At procedure]
- TIMI Flow Grade [Time frame: At procedure]
Eligibility criteria
Inclusion criteria
- Adult patients ≥18 years of age
- Patients who underwent DCB angioplasty for in-stent restenosis
Exclusion criteria
\- Lack of clinical outcome assessment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Wanha W, Iwanczyk S, Tajstra M, Cortese B. How to treat coronary in-stent restenosis? Recent advances and their practical implications: State-of-the-Art Review. Kardiol Pol. 2025;83(5):556-569. doi: 10.33963/v.phj.105954. Epub 2025 May 14. PMID 40365890
- Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028. PMID 21109112
- Latib A, Mussardo M, Ielasi A, Tarsia G, Godino C, Al-Lamee R, Chieffo A, Airoldi F, Carlino M, Montorfano M, Colombo A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosis. JACC Cardiovasc Interv. 2011 Feb;4(2):155-64. doi: 10.1016/j.jcin.2010.09.027. PMID 21349453
- Mauri L, Bonan R, Weiner BH, Legrand V, Bassand JP, Popma JJ, Niemyski P, Prpic R, Ho KK, Chauhan MS, Cutlip DE, Bertrand OF, Kuntz RE. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial. Am J Cardiol. 2002 Nov 15;90(10):1079-83. doi: 10.1016/s0002-9149(02)02773-x. PMID 12423707
- Bonaventura K, Schwefer M, Yusof AKM, Waliszewski M, Krackhardt F, Steen P, Ocaranza R, Zuhdi AS, Bang LH, Graf K, Bock U, Chin K. Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study. Adv Ther. 2020 May;37(5):2210-2223. doi: 10.1007/s12325-020-01320-2. Epub 2020 Apr 9. PMID 32274746
Identifiers
NCT: NCT07391033 · PICCOLETO XI