The PICCOLETO XI A-PREP Study (PICCOLETO-XI)

January 29, 2026 updated by: Fondazione Ricerca e Innovazione Cardiovascolare ETS

Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.

Description

Inclusion Criteria:

  • Adult patients ≥18 years of age
  • Patients who underwent DCB angioplasty for in-stent restenosis

Exclusion Criteria:

- Lack of clinical outcome assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Aggressive Lesion Preparation
Patients who underwent lesion preparation using cutting/Wolverine balloons, scoring balloons (any brand), and/or OPN balloons prior to DCB angioplasty for ISR.
Standard Lesion Preparation
Patients who underwent lesion preparation using semi-compliant balloons and/or non-compliant balloons prior to DCB angioplasty for ISR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 12 months
Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Death
Time Frame: 12 months and longest available follow-up
Death attributed to cardiovascular causes, including death from unknown cause.
12 months and longest available follow-up
Non-fatal Myocardial Infarction
Time Frame: 12 months and longest available follow-up
Non-fatal myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction.
12 months and longest available follow-up
Target Lesion Revascularization (TLR)
Time Frame: 12 months and longest available follow-up
Any repeat revascularization (percutaneous or surgical) of the target lesion.
12 months and longest available follow-up
Target Vessel Myocardial Infarction (TV-MI)
Time Frame: 12 months and longest available follow-up
Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria.
12 months and longest available follow-up
BARC Major Bleeding
Time Frame: 12 months and longest available follow-up
Bleeding Academic Research Consortium (BARC) major bleeding events (type 3-5).
12 months and longest available follow-up
Procedural Success
Time Frame: At procedure
Successful DCB angioplasty with residual stenosis less than 30% and TIMI flow grade 3 without major procedural complications.
At procedure
Post-procedural Diameter Stenosis
Time Frame: At procedure
Percentage of diameter stenosis after DCB angioplasty assessed by quantitative coronary angiography.
At procedure
Angiographic Dissection
Time Frame: At procedure
Presence and type of coronary dissection after lesion preparation and DCB treatment.
At procedure
TIMI Flow Grade
Time Frame: At procedure
Thrombolysis In Myocardial Infarction (TIMI) flow grade assessment post-procedure.
At procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Investigators

  • Principal Investigator: Bharat Khialani, MD, Tan Tock Seng Hospital, National Healthcare Group, Singapore
  • Principal Investigator: Filippo Luca Gurgoglione, MD, PhD, Department of Cardiology, Parma University Hospital, Parma, Italy
  • Study Chair: Bernardo Cortese, MD, Fondazione Ricerca e Innovazione Cardiovascolare ETS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Wańha W, Iwańczyk 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.
  • 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;56:1897-907. doi: 10.1016/j.jacc.2010.07.028.
  • 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;4:155-64. doi: 10.1016/j.jcin.2010.09.027.
  • Mauri L, Bonan R, Weiner BH, et al. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial. Am J Cardiol. 2002;90(10):1079-1083. doi: 10.1016/S0002-9149(02)02773-X.
  • Bonaventura K, Schwefer M, Yusof AKM, Waliszewski M, Krackhardt F, Steen P, Ocaranza R, Zuhdi AS, Bang LH, Graf K, Böck 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PICCOLETO XI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data may be made available to qualified researchers upon reasonable request after study completion and primary publication, subject to appropriate data use agreements and ethics committee approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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