Cardiovascular DiseasesPICCOLETO IINCT03899818
Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
A study testing drug-eluting balloon and drug-eluting stent in people with Cardiovascular Diseases, run by Fatebenefratelli and Ophthalmic Hospital.
Trial summary
This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- drug-eluting balloon and drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age >18 years.
- Stable or unstable coronary artery disease.
- Native coronary artery lesion in vessel with diameter <2.75 mm.
- Clinical indication to percutaneous coronary intervention (PCI).
Who cannot join
- Enrolment in another study with any investigational drug or device.
- Acute or recent (≤48 hours) myocardial infarction.
- Creatinine clearance <50 ml/min.
- Left ventricle ejection fraction <30%.
- Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
- Heavily calcified and severely tortuous lesions.
About this study
Official title: Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina
- Conditions
- Cardiovascular Diseases
- Being tested
- drug-eluting balloon, drug-eluting stent
- Keywords
- small vessels, drug coated balloon
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting balloonDevice
Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)
drug-eluting stentDevice
Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).
| Study group | Role | What they receive |
|---|---|---|
| new generation DEB | Other | drug-eluting balloon (DEB) Receives: Device: drug-eluting balloon |
| second generation DES | Other | standard therapy with second generation drug-eluting stent (DES) Receives: Device: drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the non-inferiority of DCB
the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery).
Measured: up to 6 months
Secondary outcomes (3)
Number of Participants with changes of vessels lumen
any differences between groups in terms of vascular changes to angiography.
Measured: up to 12 months
Concentration in blood chemistry
changes of concentration in blood chemistry between the groups
Measured: up to 6 months
Number of Participants with adverse events
appearance of major cardiovascular adverse events
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2014
- Primary completion25 Apr 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatebenefratelli and Ophthalmic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernardo Cortese, Fatebenefratelli and Ophthalmic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899818
- Sponsor's protocol ID
- PICCOLETO2
- Acronym
- PICCOLETO II
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fezzi S, Trevisanello A, Buccheri D, Borgi M, Orrego PS, Zoccai GB, Cortese B. Physiological Performance of Drug-Coated Balloons in Small Coronary Arteries PICCOLETO II muFR. Catheter Cardiovasc Interv. 2025 Feb;105(3):643-649. doi: 10.1002/ccd.31376. Epub 2024 Dec 24.
PubMed 39718036Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.
PubMed 37164603Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25.
PubMed 33248978
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
- ClinicalTrials.gov ID
- NCT03899818
- Acronym / sponsor ID
- PICCOLETO II / PICCOLETO2
- Conditions
- Cardiovascular Diseases
- Keywords
- small vessels, drug coated balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fatebenefratelli and Ophthalmic HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 2 Apr 2019 (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.
This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new generation DEB | Other | Device: drug-eluting balloondrug-eluting balloon (DEB) |
| second generation DES | Other | Device: drug-eluting stentstandard therapy with second generation drug-eluting stent (DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years.
- Stable or unstable coronary artery disease.
- Native coronary artery lesion in vessel with diameter <2.75 mm.
- Clinical indication to percutaneous coronary intervention (PCI).
Key exclusion criteria (6 listed)
- Enrolment in another study with any investigational drug or device.
- Acute or recent (≤48 hours) myocardial infarction.
- Creatinine clearance <50 ml/min.
- Left ventricle ejection fraction <30%.
- Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug-eluting balloonPatients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES) | Device | new generation DEB |
| drug-eluting stentPatients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). | Device | second generation DES |
Primary outcome
Verify the non-inferiority of DCB
Time frame: up to 6 months
the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery).
3 secondary outcomes
Number of Participants with changes of vessels lumen
Time frame: up to 12 months
Concentration in blood chemistry
Time frame: up to 6 months
Number of Participants with adverse events
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 39718036Fezzi S, Trevisanello A, Buccheri D, Borgi M, Orrego PS, Zoccai GB, Cortese B. Physiological Performance of Drug-Coated Balloons in Small Coronary Arteries PICCOLETO II muFR. Catheter Cardiovasc Interv. 2025 Feb;105(3):643-649. doi: 10.1002/ccd.31376. Epub 2024 Dec 24.
- Derived from this study: PubMed 37164603Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.
- Derived from this study: PubMed 33248978Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2840-2849. doi: 10.1016/j.jcin.2020.08.035. Epub 2020 Nov 25.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing drug-eluting balloon and drug-eluting stent in people with Cardiovascular Diseases, run by Fatebenefratelli and Ophthalmic Hospital.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 2 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the non-inferiority of DCB (time frame: up to 6 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 NCT03899818, which also lists 3 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 2 Apr 2019.