Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels
NCT ID: NCT04893291
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1820 participants
INTERVENTIONAL
2021-11-16
2030-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus Eluting Stent
Everolimus Eluting Stent
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
Magic Touch Sirolimus Coated Balloon
Sirolimus Coated Balloon
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
Interventions
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Everolimus Eluting Stent
Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
Sirolimus Coated Balloon
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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
18 Years
ALL
No
Sponsors
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Fondazione Ricerca e Innovazione Cardiovascolare ETS
OTHER
Responsible Party
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Locations
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Bangladesh Specialized Hospital Lt
Dhaka, , Bangladesh
Kurmitola General Hospital
Dhaka, , Bangladesh
LABAID Cardiac Hospital
Dhaka, , Bangladesh
National Heart Foundation Hospital & Research Institute
Dhaka, , Bangladesh
National Institute of Cardiovascular Disease
Dhaka, , Bangladesh
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
INC (National Institute of Cardiology),
Rio de Janeiro, , Brazil
InCor (Heart Institute)
São Paulo, , Brazil
Institute Dante Pazzanese of Cardiology
São Paulo, , Brazil
Hospital Santa Isabel R. Frei Cornélio
Ubá, , Brazil
Jurong Park Medical Centre JPMC
Bandar Seri Begawan, , Brunei
Clinique Louis Pasteur
Essey-lès-Nancy, , France
Groupe Hospitalier de La Rochelle
La Rochelle, , France
Les Hôpitaux de Chartres, Hôpital Louis Pasteur
Le Coudray, , France
Hôpital Prive du Confluent, 4 Rue Éric Tabarly
Nantes, , France
Clinique Saint-Hilaire
Rouen, , France
Centre Hospitalier de SaintMalo
St-Malo, , France
Ospedale San Giuseppe Moscati
Aversa, , Italy
Fondazione Poliambulanza
Brescia, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Ospedale Civile Sant'Andrea
La Spezia, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto clinico Sant'Ambrogio
Milan, , Italy
Clinica Polispecialistica San Carlo
Paderno Dugnano, , Italy
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
Palermo, , Italy
Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
Palermo, , Italy
Ospedale Sandro Pertini
Roma, , Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Ospedale S. Antonio Abate
Trapani, , Italy
Azienda Ospedaliera Universitaria Integrata
Verona, , Italy
Hospital Queen Elizabeth II
Kota Kinabalu, , Malaysia
University Malaya Medical Centre (Teaching and Research Hospital)
Kuala Lumpur, , Malaysia
OLVG Onze Lieve Vrouwe Gasthuis location East
Amsterdam, , Netherlands
Albert Schweitzer Hospital
Dordrecht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Maasstad Hospital
Rotterdam, , Netherlands
Haga Hospital Els Borst
The Hague, , Netherlands
1st Military Institute of Medicine
Lublin, , Poland
Heliodors Święcicki Clinical Univeristy Hospital, Ul
Poznan, , Poland
Hospital General Universitario de Ciudad Real (HGUCR)
Ciudad Real, , Spain
Hospital Universitario Lucus Augusti (HULA)
Lugo, , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla (HUMV)
Santander, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital Alvaro Cunqueiro-University Hospital of Vigo
Vigo, , Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, , Spain
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
University Hospitals Birmingham
Birmingham, , United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Altnagelvin Area Hospital
Londonderry, , United Kingdom
Countries
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References
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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.
Cortese 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.
Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011 May;7 Suppl K:K53-6. doi: 10.4244/EIJV7SKA9.
Latib 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.
Cortese 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.
Cortese 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.
Jeger 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.
B. 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.
Lemos 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.
Cortese 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.
Cortese 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.
Cortese 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.
Kleber 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.
Cortese 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.
Onishi T, Onishi Y, Kobayashi I, Sato Y. Late lumen enlargement after drug-coated balloon angioplasty for de novo coronary artery disease. Cardiovasc Interv Ther. 2021 Jul;36(3):311-318. doi: 10.1007/s12928-020-00690-2. Epub 2020 Jul 9.
Greco A, Sciahbasi A, Abizaid A, Mehran R, Rigattieri S, de la Torre Hernandez JM, Alfonso F, Cortese B. Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):544-552. doi: 10.1002/ccd.30358. Epub 2022 Sep 2.
Other Identifiers
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TRANSFORM II
Identifier Type: -
Identifier Source: org_study_id