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New balloon treatment shows promise for long heart blockages

NCT ID NCT05471245

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a special balloon coated with sirolimus, a drug that helps prevent arteries from narrowing again after angioplasty. It included 110 adults with stable or unstable coronary artery disease who had long blockages (at least 25 mm) in their heart arteries. The main goals were to measure how well the artery stayed open after 9 months and to track any serious heart problems like heart attacks or the need for another procedure.

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

110 people

The number who actually took part.

Started

May 2023

Finished

Oct 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Age \>18 years 2. Patients presenting with stable or unstable coronary artery disease (CAD) eligible for percutaneous coronary intervention (PCI) with de novo CAD in one or two separates major epicardial territories and at least one lesion suitable for sirolimus coated balloon (SCB); 3. Reference vessel diameter (RVD) at the SCB target site ≥2.0 mm and ≤4.0 mm (by visual estimation and/or quantitative coronary angiography); 4. Lesion length at the SCB target site ≥25 mm; 5. Successful lesion preparation (full and homogenous pre-dilatation balloon expansion without type C-F dissection and/or TIMI flow=3 at the SCB target site; 6. SCB-target lesion located in the same or other vessels treated by drug-eluting stent (DES) implantation; 7. Patient able to understand and provide informed consent and comply with all study procedures including 9 months angiographic follow-up. Exclusion criteria: 1. Patients participating in another clinical evaluation; 2. Age \<18 years; 3. Cardiogenic shock; 4. Pregnancy or breastfeeding women; pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception; 5. Thrombus containing lesion; 6. Unprotected left main as a target lesion unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel; 7. Comorbidities with life expectancy \<6 months; 8. Aorto-ostial target lesion (within 3 mm of the aorta junction); unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel; 9. Target lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft; 10. Every known allergy, intolerance or hypersensitivity to any medication used during the procedure and to drugs recommended after the procedure (e.g. aspirin, clopidogrel, ticagrelor, prasugrel); 11. Severe chronic kidney disease (glomerular filtration rate\<30 ml/min/1.73 m2); 12. Platelet count \<50,000cells/mm; 13. Stroke within the previous 6 months; 14. RVD at the SCB target site \<2.0 mm or \>4.0 mm (by visual estimation and/or QCA); target lesion with RVD larger than 4 mm can be treated with a DES and SCB inflated in other segments of the same or other vessels.

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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.

Contacts and locations

Locations

  • AULSS 2 Marca Trevigiana Ospedale di Conegliano

    Conegliano, Italy/TV, 31015, Italy

  • Centro Cardiologico Monzino

    Milan, Italy/MI, 20138, Italy

  • IRCCS Ospedale Galeazzi Sant'Ambrogio

    Milan, Italy/MI, 20157, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Italy/MI, 20132, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy/MI, 20089, Italy

  • Policlinico Tor Vergata

    Rome, Italy/RM, 00133, Italy

  • Policlinico Universitario Campus Bio-Medico

    Roma, Italy/RM, 00128, Italy

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