New balloon treatment shows promise for long heart blockages
NCT ID NCT05471245
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.
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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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110 people
The number who actually took part.
- Started
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May 2023
- Finished
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Oct 2025
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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. 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
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AULSS 2 Marca Trevigiana Ospedale di Conegliano
Conegliano, Italy/TV, 31015, Italy
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Centro Cardiologico Monzino
Milan, Italy/MI, 20138, Italy
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IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy/MI, 20157, Italy
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IRCCS Ospedale San Raffaele
Milan, Italy/MI, 20132, Italy
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Istituto Clinico Humanitas
Rozzano, Italy/MI, 20089, Italy
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Policlinico Tor Vergata
Rome, Italy/RM, 00133, Italy
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Policlinico Universitario Campus Bio-Medico
Roma, Italy/RM, 00128, Italy
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