An interventional study of sirolimus-eluting balloon (Selution) and paclitaxel-eluting balloon (SeQuent Please Neo) in Coronary Artery Disease, Stenosis Coronary and Coronary Artery Lesion, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Not applicable, Interventional, and Treatment
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 129th largest by planned enrollment of the 189 interventional ones that give a count, is one of 12 that started in 2024, is one of 81 with no phase, reaches primary completion later than 48 of the 70 other live ones, and was the 277th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now. Recruiting first, the newest first:
Centro Cardiologico Monzino · Sites in Italy
IRCCS San Raffaele · Sites in Italy
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy
Centro Cardiologico Monzino · Sites in Italy
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy, Poland, Romania and 1 more country
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
302 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 41 · Phase 4 57
First in 2000; this study’s year is marked. 12 started in 2024.
This study's planned enrollment of 140 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
101 of 302 have an industry lead sponsor. The 10 most frequent:
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS has 3 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) and Fractional Flow Reserve (FFR) at 12 months follow-up.
This is a prospective, randomized, multicenter, no-profit and post-market study in subjects with small vessels, i.e. at least one de novo lesion in a small vessel (>2.00 mm and ≤3.00). Vessel size is evaluated by visual estimation. It is possible to include only one study lesion per patient. For the purposes of this study, in cases of diffuse coronary artery disease where overlapped DCB are utilized for the treatment of the lesion, this will be considered as a single lesion. In case of a successful predilatation (i.e. no major (type D, E, F) angiographic dissections, residual stenosis ≤ 30% and TIMI flow = 3), the subject will be randomized in a 1:1 fashion to SelutionTM or SeQuent Please NeoTM. Randomization will be stratified according to DCB length (\< 30 mm or ≥ 30 mm) in order to include at least 100 patients treated with DCB of 30 mm or longer. Measurements of intramyocardial resistances, after lesion preparation prior to DCB treatment and after DCB treatment (2 measurements), will be limited to a maximum of 100 lesions treated with DCB ≥ 30 mm. Given the lack of literature data on intramyocardial resistance measurements, a minimum of 100 subjects is considered necessary to provide an initial evaluation of these parameters. With a total sample size of 140 patients for the study, it will be allowed to enroll up to 40 patients treated with DCB \< 30 mm. Once this limit is reached, only patients treated with DCB ≥ 30 mm will be enrolled while maintaining a 1:1 randomization ratio. During the index procedure, it is possible to treat other not study lesions (if applicable) with any other commercial device (e.g. drug-eluting stent) if they are located in a different epicardial territory than the study target lesion. All not studylesions should be treated prior to study target lesion procedure, and should be successful and uncomplicated.
Follow-up by phone call will occur at 1 and 6 months post-PCI. At 12 months all subjects will perform an angiographic follow up at the same site where the index procedure was performed. Quantitative Coronary Angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and on follow up angiography by the imaging core lab. FFR assessment will be performed at the time of follow-up angiography.
All subjects must receive dual anti-platelet therapy (DAPT), being aspirin (ASA) and P2Y12 inhibition therapy for at least 1 month after drug coated balloon PCI or according to standard local practice (with the choice of agent left to the discretion of the investigator), followed by ASA monotherapy indefinitely. However, in case the subject had recent ACS or is receiving additional drug-eluting stents, DAPT must be given according to local standard of care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Currently participating in another trial
Angiographic exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DCB angioplasty with a sirolimus-eluting balloon
Device: sirolimus-eluting balloon (Selution)
DCB angioplasty with a paclitaxel-eluting balloon
Device: paclitaxel-eluting balloon (SeQuent Please Neo)
PCI treatment with DCB, in particular sirolimus coated balloon
PCI treatment with DCB, in particular paclitaxel coated balloon
In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure. Net Gain is defined as acute gain at the time of the index procedure minus late loss at the time of follow-up angiography.
Time frame: 12 months post-procedure
Fractional Flow Reserve (FFR)
FFR (absolute value) at 12 months post-procedure
Time frame: From enrollment to the end of treatment at 12 months
Device success (lesion based)
Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of \<30%. I
Time frame: 12 months post-procedure
Procedure success
Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of \<30 % without the occurrence of TLF during the index procedure hospital stay).
Time frame: 12 months post-procedure
Angiographic outcomes 1
late lumen loss
Time frame: 12 months post-procedure
Angiographic outcomes 2
minimal lumen diameter
Time frame: 12 months post-procedure
Angiographic outcomes 3
percent diameter stenosis
Time frame: 12 months post-procedure
Angiographic outcomes 4
restenosis rate
Time frame: 12 months post-procedure
Device oriented Composite Endpoint (DoCE/ TLF)
DoCE/ TLF which is composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR)
Time frame: 12 months post-procedure
Acute/subacute/early/late vessel thrombosis
Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient left the catheterization lab.
Time frame: 12 months post-procedure
Periprocedural myocardial infarction
Periprocedural myocardial infarction according to the Fourth Universal definition of Myocardial Infarction
Time frame: From enrollment to the end of treatment at 12 months
PCI related myocardial injury
PCI related myocardial injury, defined according to the Fourth Universal definition of Myocardial Infarction estimating the absolute value of troponin pre-discharge or within 3-8 hours post-PCI
Time frame: From enrollment to the end of treatment at 12 months
Absolute difference in CFR for the first 100 patients treated with DCB ≥ 30 mm
Absolute difference in CFR measured with a dedicated system (PressureWire™ X Guidewire and Coroventis CoroFlow Cardiovascular System, Abbott)
Time frame: baseline
Absolute variation in IMR for the first 100 patients treated with DCB ≥ 30 mm
Absolute variation in IMR from the first assessment (after predilation) to the second assessment (after DCB angioplasty)
Time frame: baseline
Absolute decrease in CFR for the first 100 patients treated with DCB ≥ 30 mm
Absolute decrease in CFR from the first assessment (after predilatation) to the second assessment (after DCB angioplasty)
Time frame: baseline
Not enrolling at this site.
Started Sep 2024 (actual). Primary completion is estimated for Aug 2027, 34 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 34 months is close to that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS