In-Stent Coronary Artery RestenosisPICCOLETO-XINCT07391033
The PICCOLETO XI A-PREP Study
An observational study of In-Stent Coronary Artery Restenosis and Coronary Artery Disease, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-Stent Coronary Artery Restenosis, Coronary Artery Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.
Who may be able to join
- Adult patients ≥18 years of age
- Patients who underwent DCB angioplasty for in-stent restenosis
Who cannot join
- Lack of clinical outcome assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Beatrice Barbano contact
About this study
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
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.
Read the 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.
- Keywords
- Drug-Coated Balloon, In-Stent Restenosis, Lesion Preparation, Cutting Balloon, Scoring Balloon, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).
Measured: 12 months
Secondary outcomes (9)
Cardiac Death
Death attributed to cardiovascular causes, including death from unknown cause.
Measured: 12 months and longest available follow-up
Non-fatal Myocardial Infarction
Non-fatal myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction.
Measured: 12 months and longest available follow-up
Target Lesion Revascularization (TLR)
Any repeat revascularization (percutaneous or surgical) of the target lesion.
Measured: 12 months and longest available follow-up
Target Vessel Myocardial Infarction (TV-MI)
Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria.
Measured: 12 months and longest available follow-up
BARC Major Bleeding
Bleeding Academic Research Consortium (BARC) major bleeding events (type 3-5).
Measured: 12 months and longest available follow-up
Procedural Success
Successful DCB angioplasty with residual stenosis less than 30% and TIMI flow grade 3 without major procedural complications.
Measured: At procedure
Post-procedural Diameter Stenosis
Percentage of diameter stenosis after DCB angioplasty assessed by quantitative coronary angiography.
Measured: At procedure
Angiographic Dissection
Presence and type of coronary dissection after lesion preparation and DCB treatment.
Measured: At procedure
TIMI Flow Grade
Thrombolysis In Myocardial Infarction (TIMI) flow grade assessment post-procedure.
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for In-Stent Coronary Artery RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bharat Khialani, MD, Principal investigator, Tan Tock Seng Hospital, National Healthcare Group, SingaporeFilippo Luca Gurgoglione, MD, PhD, Principal investigator, Department of Cardiology, Parma University Hospital, Parma, ItalyBernardo Cortese, MD, Study chair, Fondazione Ricerca e Innovazione Cardiovascolare ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391033
- Sponsor's protocol ID
- PICCOLETO XI
- Acronym
- PICCOLETO-XI
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 40365890Dangas 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.
PubMed 21109112Latib 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.
PubMed 21349453Mauri 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.
PubMed 12423707Bonaventura 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.
PubMed 32274746
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07391033
- Acronym / sponsor ID
- PICCOLETO-XI / PICCOLETO XI
- Keywords
- Drug-Coated Balloon, In-Stent Restenosis, Lesion Preparation, Cutting Balloon, Scoring Balloon, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETSUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.
Key inclusion criteria (2 listed)
- Adult patients ≥18 years of age
- Patients who underwent DCB angioplasty for in-stent restenosis
Key exclusion criteria (1 listed)
- Lack of clinical outcome assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months
Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 40365890Wanha 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.
- Background: PubMed 21109112Dangas 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.
- Background: PubMed 21349453Latib 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.
- Background: PubMed 12423707Mauri 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.
- Background: PubMed 32274746Bonaventura 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice Barbano contact
Bharat Khialani, MD principal investigator
Tan Tock Seng Hospital, National Healthcare Group, Singapore
Filippo Luca Gurgoglione, MD, PhD principal investigator
Department of Cardiology, Parma University Hospital, Parma, Italy
Bernardo Cortese, MD study chair
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Questions about this trial
What is this clinical trial studying?
An observational study of In-Stent Coronary Artery Restenosis and Coronary Artery Disease, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filippo Luca Gurgoglione, MD, PhD (+393312048150, filippolucagurgoglione@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07391033, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.