Coronary Artery DiseaseTRANSFORM IINCT04893291
Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
A study testing Everolimus Eluting Stent and Sirolimus Coated Balloon in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS at 53 sites in 11 countries.
Trial summary
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis
- What is being tested?
- Everolimus Eluting Stent and Sirolimus Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 53 sitesin 11 countries
- Study dates
- 16 Nov 2021to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years;
- all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes);
- native coronary artery lesion in a vessel with diameter >2.0 mm and ≦3.5 mm at visual estimation;
- maximum lesion length: 50 mm.
- informed consent to participate in the study.
Who cannot join
- patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
- patients participating in another clinical study;
- subject is a woman who is pregnant or nursing (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);
- creatinine clearance <30 ml/min;
- left ventricular ejection fraction <30%;
- life expectancy <12 months;
Show all 19Show fewer
- ST-elevation myocardial infarction in the previous 48 hours;
- visible thrombus at lesion site;
- culprit lesion stenosis >99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow <2;
- target lesion/vessel with any of the following characteristics:
- concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery);
- pre-dilatation of the target lesion not performed or not successful (residual stenosis >30%);
- severe calcification of the target vessel, at lesion site but also proximally;
- highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement;
- previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery);
- bifurcation lesion where side branch treatment is anticipated;
- left main stem stenosis >50%;
- target lesion is in left main stem
- Lesion is located within asaphenous vein graft
Trial locations and contacts
53 sites in 11 countries.
53 sites in 11 countries
Italy14 sites
Ospedale San Giuseppe Moscati
Aversa
Fondazione Poliambulanza
Brescia, 25124
Ospedale Policlinico San Martino
Genova
Ospedale Civile Sant'Andrea
La Spezia
ASST Grande Ospedale Metropolitano Niguarda
Milan
Istituto clinico Sant'Ambrogio
Milan
Clinica Polispecialistica San Carlo
Paderno Dugnano, 20037
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
Palermo
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo
Ospedale Sandro Pertini
Roma, 00157
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma
Policlinico Tor Vergata
Roma
Ospedale S. Antonio Abate
Trapani
Azienda Ospedaliera Universitaria Integrata
Verona
Spain8 sites
Hospital General Universitario de Ciudad Real (HGUCR)
Ciudad Real
Hospital Universitario Lucus Augusti (HULA)
Lugo
Hospital de La Princesa
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Marqués de Valdecilla (HUMV)
Santander
Hospital Universitario y Politécnico La Fe
Valencia
Hospital Alvaro Cunqueiro-University Hospital of Vigo
Vigo
Hospital Universitario de Araba
Vitoria-Gasteiz
France6 sites
Clinique Louis Pasteur
Essey-lès-Nancy
Groupe Hospitalier de La Rochelle
La Rochelle
Les Hôpitaux de Chartres, Hôpital Louis Pasteur
Le Coudray
Hôpital Prive du Confluent, 4 Rue Éric Tabarly
Nantes
Clinique Saint-Hilaire
Rouen
Centre Hospitalier de SaintMalo
St-Malo
Bangladesh5 sites
Bangladesh Specialized Hospital Lt
Dhaka
Kurmitola General Hospital
Dhaka
LABAID Cardiac Hospital
Dhaka
National Heart Foundation Hospital & Research Institute
Dhaka
National Institute of Cardiovascular Disease
Dhaka
Brazil5 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre
INC (National Institute of Cardiology),
Rio de Janeiro
InCor (Heart Institute)
São Paulo
Institute Dante Pazzanese of Cardiology
São Paulo
Hospital Santa Isabel R. Frei Cornélio
Ubá
Netherlands5 sites
OLVG Onze Lieve Vrouwe Gasthuis location East
Amsterdam
Albert Schweitzer Hospital
Dordrecht
Erasmus University Medical Center
Rotterdam
Maasstad Hospital
Rotterdam
Haga Hospital Els Borst
The Hague
United Kingdom4 sites
University Hospitals Birmingham
Birmingham
Golden Jubilee National Hospital
Clydebank
St Bartholomew's Hospital
London
Altnagelvin Area Hospital
Londonderry
Malaysia2 sites
Hospital Queen Elizabeth II
Kota Kinabalu
University Malaya Medical Centre (Teaching and Research Hospital)
Kuala Lumpur
Poland2 sites
1st Military Institute of Medicine
Lublin
Heliodors Święcicki Clinical Univeristy Hospital, Ul
Poznan
Brunei1 site
Jurong Park Medical Centre JPMC
Bandar Seri Begawan
About this study
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Read the detailed description
The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter <3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Being tested
- Everolimus Eluting Stent, Sirolimus Coated Balloon
- Keywords
- DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus Eluting StentDevice
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
Sirolimus Coated BalloonDevice
Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Everolimus Eluting Stent | Active comparator | Not described Receives: Device: Everolimus Eluting Stent |
| Magic Touch Sirolimus Coated Balloon | Experimental | Not described Receives: Device: Sirolimus Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of target Lesion Failure (TLF) at 12 Months
Non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of target lesion failure (TLF), a composite clinical endpoint, at 12 months.
Measured: 12 Months
Number of NACEs
Verify the superiority of the study device in terms of net adverse clinical events (NACE), a composite endpoint including all-cause death, myocardial infarction (MI), ischemic stroke, and major bleedings following the Bleeding Academic Research Consortium (BARC) types 3 or 5 definition.
Measured: 12 Months
Secondary outcomes (7)
Cardiac death
The occurrence of cardiac death
Measured: 6, 12, 24, 36, 48 and 60 months
Death of any cause;
The occurrence of death of any cause;
Measured: 6, 12, 24, 36, 48 and 60 months
Q-wave MI
The occurrence of Q-wave MI;
Measured: 6, 12, 24, 36, 48 and 60 months
MI
The occurrence of any MI;
Measured: 6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
The occurrence of TLR;
Measured: 6, 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
The occurrence of target vessel revascularization
Measured: 6, 12, 24, 36, 48 and 60 months
Bleeding
The occurrence of bleedings following the BARC classification
Measured: 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start16 Nov 2021
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893291
- Sponsor's protocol ID
- TRANSFORM II
- Acronym
- TRANSFORM II
- Status last verified
- Feb 2026
- First submitted
- 13 May 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014 Jan;11(1):13-23. doi: 10.1038/nrcardio.2013.165. Epub 2013 Nov 5.
PubMed 24189405Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010 Aug;96(16):1291-6. doi: 10.1136/hrt.2010.195057.
PubMed 20659948Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011 May;7 Suppl K:K53-6. doi: 10.4244/EIJV7SKA9.
PubMed 22027728Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.
PubMed 23158530Cortese B, Sgueglia GA, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A; Italian Society of Interventional Cardiology (SICI-GISE). [SICI-GISE position paper on drug-coated balloon use in the coronary district]. G Ital Cardiol (Rome). 2013 Oct;14(10):681-9. doi: 10.1714/1335.14836. Italian.
PubMed 24121894Cortese B, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A, Silva PL, Sgueglia GA; Italian Society of Interventional Cardiology. Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv. 2014 Feb 15;83(3):427-35. doi: 10.1002/ccd.25149. Epub 2013 Sep 23.
PubMed 23934956Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
PubMed 30170854B. Cortese et Al., PICCOLETO II study, JACC Interventions, 2020, in press
Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R, Kleber FX, Latib A, Clever YP, Ewen S, Bohm M, Yang Y, Lansky A, Mahfoud F. Survival After Coronary Revascularization With Paclitaxel-Coated Balloons. J Am Coll Cardiol. 2020 Mar 10;75(9):1017-1028. doi: 10.1016/j.jacc.2019.11.065.
PubMed 32138961Lemos PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, Christians U, Kharlamov A, Doshi M, Sojitra P, van Beusekom HM, Serruys PW. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013 May 20;9(1):148-56. doi: 10.4244/EIJV9I1A21.
PubMed 23685303Cortese B, di Palma G, Latini RA, Elwany M, Orrego PS, Seregni RG. Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry. Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):487-491. doi: 10.1016/j.carrev.2017.03.025. Epub 2017 Mar 25.
PubMed 28365415Cortese B, Pellegrini D, Latini RA, Di Palma G, Perotto A, Orrego PS. Angiographic performance of a novel sirolimus-coated balloon in native coronary lesions: the FAtebenefratelli SIrolimus COated NATIVES prospective registry. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):471-476. doi: 10.2459/JCM.0000000000000806.
PubMed 30994510Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.
PubMed 32740442Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.
PubMed 25349065Cortese B, Silva Orrego P, Agostoni P, Buccheri D, Piraino D, Andolina G, Seregni RG. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015 Dec 28;8(15):2003-2009. doi: 10.1016/j.jcin.2015.08.029. Epub 2015 Nov 25.
PubMed 26627997
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
- ClinicalTrials.gov ID
- NCT04893291
- Acronym / sponsor ID
- TRANSFORM II / TRANSFORM II
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Keywords
- DCB, EES, Optical Coherence Tomography (OCT), Sirolimus, Everolimus, TLF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,820 participants (estimated)
- Lead sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETSUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Detailed description
The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter <3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus Eluting Stent | Active comparator | Device: Everolimus Eluting Stent |
| Magic Touch Sirolimus Coated Balloon | Experimental | Device: Sirolimus Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >18 years;
- all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes);
- native coronary artery lesion in a vessel with diameter >2.0 mm and ≦3.5 mm at visual estimation;
- maximum lesion length: 50 mm.
- informed consent to participate in the study.
Key exclusion criteria (19 listed)
- patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
- patients participating in another clinical study;
- subject is a woman who is pregnant or nursing (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);
- creatinine clearance <30 ml/min;
- left ventricular ejection fraction <30%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus Eluting StentPatients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care | Device | Everolimus Eluting Stent |
| Sirolimus Coated BalloonPatients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care | Device | Magic Touch Sirolimus Coated Balloon |
Primary outcome
Number of target Lesion Failure (TLF) at 12 Months
Time frame: 12 Months
Non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of target lesion failure (TLF), a composite clinical endpoint, at 12 months.
Number of NACEs
Time frame: 12 Months
Verify the superiority of the study device in terms of net adverse clinical events (NACE), a composite endpoint including all-cause death, myocardial infarction (MI), ischemic stroke, and major bleedings following the Bleeding Academic Research Consortium (BARC) types 3 or 5 definition.
7 secondary outcomes
Cardiac death
Time frame: 6, 12, 24, 36, 48 and 60 months
Death of any cause;
Time frame: 6, 12, 24, 36, 48 and 60 months
Q-wave MI
Time frame: 6, 12, 24, 36, 48 and 60 months
MI
Time frame: 6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Time frame: 6, 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)
Time frame: 6, 12, 24, 36, 48 and 60 months
Bleeding
Time frame: 6, 12, 24, 36, 48 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background: PubMed 24189405Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014 Jan;11(1):13-23. doi: 10.1038/nrcardio.2013.165. Epub 2013 Nov 5.
- Background: PubMed 20659948Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010 Aug;96(16):1291-6. doi: 10.1136/hrt.2010.195057.
- Background: PubMed 22027728Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011 May;7 Suppl K:K53-6. doi: 10.4244/EIJV7SKA9.
- Background: PubMed 23158530Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.
- Background: PubMed 24121894Cortese B, Sgueglia GA, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A; Italian Society of Interventional Cardiology (SICI-GISE). [SICI-GISE position paper on drug-coated balloon use in the coronary district]. G Ital Cardiol (Rome). 2013 Oct;14(10):681-9. doi: 10.1714/1335.14836. Italian.
- Background: PubMed 23934956Cortese B, Berti S, Biondi-Zoccai G, Colombo A, Limbruno U, Bedogni F, Cremonesi A, Silva PL, Sgueglia GA; Italian Society of Interventional Cardiology. Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv. 2014 Feb 15;83(3):427-35. doi: 10.1002/ccd.25149. Epub 2013 Sep 23.
- Background: PubMed 30170854Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
- BackgroundB. Cortese et Al., PICCOLETO II study, JACC Interventions, 2020, in press
- Background: PubMed 32138961Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R, Kleber FX, Latib A, Clever YP, Ewen S, Bohm M, Yang Y, Lansky A, Mahfoud F. Survival After Coronary Revascularization With Paclitaxel-Coated Balloons. J Am Coll Cardiol. 2020 Mar 10;75(9):1017-1028. doi: 10.1016/j.jacc.2019.11.065.
- Background: PubMed 23685303Lemos PA, Farooq V, Takimura CK, Gutierrez PS, Virmani R, Kolodgie F, Christians U, Kharlamov A, Doshi M, Sojitra P, van Beusekom HM, Serruys PW. Emerging technologies: polymer-free phospholipid encapsulated sirolimus nanocarriers for the controlled release of drug from a stent-plus-balloon or a stand-alone balloon catheter. EuroIntervention. 2013 May 20;9(1):148-56. doi: 10.4244/EIJV9I1A21.
- Background: PubMed 28365415Cortese B, di Palma G, Latini RA, Elwany M, Orrego PS, Seregni RG. Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry. Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):487-491. doi: 10.1016/j.carrev.2017.03.025. Epub 2017 Mar 25.
- Background: PubMed 30994510Cortese B, Pellegrini D, Latini RA, Di Palma G, Perotto A, Orrego PS. Angiographic performance of a novel sirolimus-coated balloon in native coronary lesions: the FAtebenefratelli SIrolimus COated NATIVES prospective registry. J Cardiovasc Med (Hagerstown). 2019 Jul;20(7):471-476. doi: 10.2459/JCM.0000000000000806.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus Eluting Stent and Sirolimus Coated Balloon in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS at 53 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Italy, Spain, France, Bangladesh, Brazil and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of target Lesion Failure (TLF) at 12 Months (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893291, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.