Heart artery balloon showdown: which works better for Medium-Small vessels?
NCT ID NCT06373601
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of drug-coated balloons (Selution sirolimus vs. SeQuent Please Neo paclitaxel) to treat narrowed coronary arteries in medium-small vessels. About 140 adults with stable angina or stabilized acute coronary syndrome will be enrolled. The main goal is to see which balloon keeps arteries more open and improves blood flow after 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects ≥18 years 2. Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values. 3. The subject has at least one de-novo lesion in a small vessel (\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion 4. Patients with target lesion to be treated with DCB \< 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients) 5. Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up 6. Subject must have completed the follow-up phase of any previous study Exclusion Criteria: 1. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) 2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure 3. Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor 4. Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months 5. Subject suffered from stroke/TIA during the last 6 months 6. LVEF \<30% 7. Platelet count \<100,000 cells/mm3 or \>400,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) 8. Known renal insufficiency (e.g. serum creatinine \>2,5 mg/dL, creatinine clearance ≤30 mL/min or eGFR ≤30 mL/min/m2), or subject on dialysis, or acute kidney failure (as per physician judgment) 9. Subject undergoing planned surgery within 1 month with the necessity to stop DAPT 10. History of bleeding diathesis or coagulopathy 11. The subject is a recipient of a heart transplant 12. Concurrent medical condition with a life expectancy of less than 12 months 13. The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up 14. Currently participating in another trial Angiographic exclusion criteria: 15. Target vessel size \>3.00 mm 16. Target vessel size ≤2.00 mm 17. Target lesion has a diameter stenosis \< 50% prior to pre-dilatation 18. Target lesion has a total occlusion or TIMI flow \< 2 prior to pre-dilatation 19. Pre-dilatation of the target lesion not performed or not successful (residual stenosis \> 30%, TIMI flow \< 3 and presence of major angiographic dissections) 20. Target lesion in left main stem 21. The target vessel contains visible thrombus 22. Aorto-ostial target lesion (within 3 mm of the aorta junction) 23. Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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ASST Papa Giovanni XXIII
RECRUITINGBergamo, Italy/Bergamo, 24127, Italy
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Azienda Ospedaliero Universitaria San Luigi Gonzaga
RECRUITINGOrbassano, Italy/Torino, 10043, Italy
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Azienda Ospedaliero Universitaria di Ferrara
WITHDRAWNFerrara, Italy/Ferrara, 44124, Italy
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Centro Cardiologico Monzino
RECRUITINGMilan, Italy/Milano, 20138, Italy
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Clinica Mediterranea
RECRUITINGNaples, Italy/Napoli, 80122, Italy
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Clinica Montevergine
RECRUITINGMercogliano, Italy/Avellino, 83013, Italy
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Fondazione Poliambulanza
RECRUITINGBrescia, Italy/Brescia, 25124, Italy
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Istituto Clinico Humanitas
RECRUITINGRozzano, Italy/Milano, 20089, Italy
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Ospedale Sant'Andrea
NOT_YET_RECRUITINGVercelli, Italy/Vercelli, 13100, Italy
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Ospedale di Rivoli
RECRUITINGRivoli, Italy/Torino, 10098ù, Italy
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