Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II (TRANSFORM II)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: Everolimus Eluting Stent; Device: Sirolimus Coated Balloon

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 Type: Interventional
• Enrollment (Estimated): 1820
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • National Heart Foundation Hospital & Research Institute
  • Dhaka, Bangladesh
    • Kurmitola General Hospital
  • Dhaka, Bangladesh
    • Bangladesh Specialized Hospital Lt
  • Dhaka, Bangladesh
    • LABAID Cardiac Hospital
  • Dhaka, Bangladesh
    • National Institute of Cardiovascular Disease
• Brazil
  • Porto Alegre, Brazil
    • Hospital de Clínicas de Porto Alegre
  • Rio de Janeiro, Brazil
    • INC (National Institute of Cardiology),
  • São Paulo, Brazil
    • Institute Dante Pazzanese of Cardiology
  • São Paulo, Brazil
    • InCor (Heart Institute)
  • Ubá, Brazil
    • Hospital Santa Isabel R. Frei Cornélio
• Brunei
  • Bandar Seri Begawan, Brunei
    • Jurong Park Medical Centre JPMC
• France
  • Essey-lès-Nancy, France
    • Clinique Louis Pasteur
  • La Rochelle, France
    • Groupe Hospitalier de La Rochelle
  • Le Coudray, France
    • Les Hôpitaux de Chartres, Hôpital Louis Pasteur
  • Nantes, France
    • Hôpital Prive du Confluent, 4 Rue Éric Tabarly
  • Rouen, France
    • Clinique Saint-Hilaire
  • St-Malo, France
    • Centre Hospitalier de SaintMalo
• Italy
  • Aversa, Italy
    • Ospedale San Giuseppe Moscati
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza
  • Genova, Italy
    • Ospedale Policlinico San Martino
  • La Spezia, Italy
    • Ospedale Civile Sant'Andrea
  • Milan, Italy
    • ASST Grande Ospedale Metropolitano Niguarda
  • Milan, Italy
    • Istituto clinico Sant'Ambrogio
  • Paderno Dugnano, Italy, 20037
    • Clinica Polispecialistica San Carlo
  • Palermo, Italy
    • A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
  • Palermo, Italy
    • Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"
  • Roma, Italy, 00157
    • Ospedale Sandro Pertini
  • Roma, Italy
    • Policlinico Tor Vergata
  • Roma, Italy
    • Azienda Ospedaliero-Universitaria Sant'Andrea
  • Trapani, Italy
    • Ospedale S. Antonio Abate
  • Verona, Italy
    • Azienda Ospedaliera Universitaria Integrata
• Malaysia
  • Kota Kinabalu, Malaysia
    • Hospital Queen Elizabeth II
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre (Teaching and Research Hospital)
• Netherlands
  • Amsterdam, Netherlands
    • OLVG Onze Lieve Vrouwe Gasthuis location East
  • Dordrecht, Netherlands
    • Albert Schweitzer Hospital
  • Rotterdam, Netherlands
    • Maasstad Hospital
  • Rotterdam, Netherlands
    • Erasmus University Medical Center
  • The Hague, Netherlands
    • Haga Hospital Els Borst
• Poland
  • Lublin, Poland
    • 1st Military Institute of Medicine
  • Poznan, Poland
    • Heliodors Święcicki Clinical Univeristy Hospital, Ul
• Spain
  • Ciudad Real, Spain
    • Hospital General Universitario de Ciudad Real (HGUCR)
  • Lugo, Spain
    • Hospital Universitario Lucus Augusti (HULA)
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital de La Princesa
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla (HUMV)
  • Valencia, Spain
    • Hospital Universitario y Politécnico La Fe
  • Vigo, Spain
    • Hospital Alvaro Cunqueiro-University Hospital of Vigo
  • Vitoria-Gasteiz, Spain
    • Hospital Universitario de Araba
• Thailand
  • Bangkok, Thailand
    • Ramathibodi Hospital, Mahidol University
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham
  • Clydebank, United Kingdom
    • Golden Jubilee National Hospital
  • London, United Kingdom
    • St Bartholomew'S Hospital
  • Londonderry, United Kingdom
    • Altnagelvin Area Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Everolimus Eluting Stent	Device: 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
Experimental: Magic Touch Sirolimus Coated Balloon	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	The occurrence of cardiac death	6, 12, 24, 36, 48 and 60 months
Death of any cause;	The occurrence of death of any cause;	6, 12, 24, 36, 48 and 60 months
Q-wave MI	The occurrence of Q-wave MI;	6, 12, 24, 36, 48 and 60 months
MI	The occurrence of any MI;	6, 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)	The occurrence of TLR;	6, 12, 24, 36, 48 and 60 months
Target Vessel Revascularization (TVR)	The occurrence of target vessel revascularization	6, 12, 24, 36, 48 and 60 months
Bleeding	The occurrence of bleedings following the BARC classification	6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

• Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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, 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.
• 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.
• 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, 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.
• B. Cortese et Al., PICCOLETO II study, JACC Interventions, 2020, in press
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Everolimus; Sirolimus; DCB; EES; Optical Coherence Tomography (OCT); TLF
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Protein Kinase Inhibitors; Antibiotics, Antineoplastic; Antifungal Agents; MTOR Inhibitors; Everolimus; Sirolimus
• Other Study ID Numbers: TRANSFORM II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No