Heart artery balloon showdown: which works better for Medium-Small vessels?

NCT ID NCT06373601

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, Italy/Bergamo, 24127, Italy

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga

    RECRUITING

    Orbassano, Italy/Torino, 10043, Italy

  • Azienda Ospedaliero Universitaria di Ferrara

    WITHDRAWN

    Ferrara, Italy/Ferrara, 44124, Italy

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, Italy/Milano, 20138, Italy

  • Clinica Mediterranea

    RECRUITING

    Naples, Italy/Napoli, 80122, Italy

  • Clinica Montevergine

    RECRUITING

    Mercogliano, Italy/Avellino, 83013, Italy

  • Fondazione Poliambulanza

    RECRUITING

    Brescia, Italy/Brescia, 25124, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Italy/Milano, 20089, Italy

  • Ospedale Sant'Andrea

    NOT_YET_RECRUITING

    Vercelli, Italy/Vercelli, 13100, Italy

  • Ospedale di Rivoli

    RECRUITING

    Rivoli, Italy/Torino, 10098ù, Italy

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