Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

Coronary Artery Disease Clinical Trial

— TRANSFORM II  

Official title:

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893291
• Other study ID #: TRANSFORM II
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: November 30, 2028

Study information

• Verified date: May 2023
• Source: Fondazione Ricerca e Innovazione Cardiovascolare ETS
• Contact: Bernardo Cortese, Dr.
• Phone: +39 348 1123968
• Email: bcortese[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1820
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

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
• 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

Locations

Country	Name	City	State
Bangladesh	National Heart Foundation Hospital & Research Institute	Dhaka
France	Clinique Louis Pasteur	Essey-lès-Nancy
France	Groupe Hospitalier de La Rochelle	La Rochelle
France	Centre Hospitalier de SaintMalo	Saint-Malo
Italy	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	Milano
Italy	Istituto clinico Sant'Ambrogio	Milano
Italy	Clinica Polispecialistica San Carlo	Paderno Dugnano
Italy	Azienda Ospedaliero-Universitaria Sant'Andrea	Roma
Italy	Ospedale Sandro Pertini	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Ospedale S. Antonio Abate	Trapani
Netherlands	OLVG Onze Lieve Vrouwe Gasthuis location East	Amsterdam
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Maasstad Hospital	Rotterdam
Spain	Hospital General Universitario de Ciudad Real (HGUCR)	Ciudad Real
Spain	Hospital Universitario de Araba	Gasteiz / Vitoria
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Ricerca e Innovazione Cardiovascolare ETS

Countries where clinical trial is conducted

Bangladesh,  France,  Italy,  Netherlands,  Spain, 

References & Publications (16)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011 May;7 Suppl K:K53-6. doi: 10.4244/EIJV7SKA9. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Coll Cardiol. 2013 Apr 16;61(15):1660. — View Citation

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. — View Citation

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. Erratum In: Cardiovasc Interv Ther. 2020 Sep 17;: — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

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