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

NCT04893291 | Active Not Recruiting

• 1 other identifier: TRANSFORM II
• Study Type: interventional
• Target: 1,820
• Locations: 10 countries
• Sites: 52

Brief 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).

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

DCB; EES; Optical Coherence Tomography (OCT); Sirolimus; Everolimus; TLF

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Cardiac death

  6, 12, 24, 36, 48 and 60 months

• Death of any cause;

  6, 12, 24, 36, 48 and 60 months

• Q-wave MI

  6, 12, 24, 36, 48 and 60 months

• MI

  6, 12, 24, 36, 48 and 60 months

• Target Lesion Revascularization (TLR)

  6, 12, 24, 36, 48 and 60 months

Study Arms (2)

Everolimus Eluting Stent

ACTIVE COMPARATOR

Device: Everolimus Eluting Stent

Magic Touch Sirolimus Coated Balloon

EXPERIMENTAL

Device: Sirolimus Coated Balloon

Interventions

Sirolimus Coated Balloon DEVICE

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

Magic Touch Sirolimus Coated Balloon

Everolimus Eluting Stent DEVICE

Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care

Everolimus Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Fondazione Ricerca e Innovazione Cardiovascolare ETS: lead

Study Sites (53)

Bangladesh Specialized Hospital Lt

Dhaka, Bangladesh

Location

Kurmitola General Hospital

Dhaka, Bangladesh

Location

LABAID Cardiac Hospital

Dhaka, Bangladesh

Location

National Heart Foundation Hospital & Research Institute

Dhaka, Bangladesh

Location

National Institute of Cardiovascular Disease

Dhaka, Bangladesh

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Location

INC (National Institute of Cardiology),

Rio de Janeiro, Brazil

Location

InCor (Heart Institute)

São Paulo, Brazil

Location

Institute Dante Pazzanese of Cardiology

São Paulo, Brazil

Location

Hospital Santa Isabel R. Frei Cornélio

Ubá, Brazil

Location

Jurong Park Medical Centre JPMC

Bandar Seri Begawan, Brunei

Location

Clinique Louis Pasteur

Essey-lès-Nancy, France

Location

Groupe Hospitalier de La Rochelle

La Rochelle, France

Location

Les Hôpitaux de Chartres, Hôpital Louis Pasteur

Le Coudray, France

Location

Hôpital Prive du Confluent, 4 Rue Éric Tabarly

Nantes, France

Location

Clinique Saint-Hilaire

Rouen, France

Location

Centre Hospitalier de SaintMalo

St-Malo, France

Location

Ospedale San Giuseppe Moscati

Aversa, Italy

Location

Fondazione Poliambulanza

Brescia, 25124, Italy

Location

Ospedale Policlinico San Martino

Genova, Italy

Location

Ospedale Civile Sant'Andrea

La Spezia, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Location

Istituto clinico Sant'Ambrogio

Milan, Italy

Location

Clinica Polispecialistica San Carlo

Paderno Dugnano, 20037, Italy

Location

A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli

Palermo, Italy

Location

Azienda Ospedaliera "Ospedali Riuniti Villa Sofia-Cervello"

Palermo, Italy

Location

Ospedale Sandro Pertini

Roma, 00157, Italy

Location

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Ospedale S. Antonio Abate

Trapani, Italy

Location

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Location

Hospital Queen Elizabeth II

Kota Kinabalu, Malaysia

Location

University Malaya Medical Centre (Teaching and Research Hospital)

Kuala Lumpur, Malaysia

Location

OLVG Onze Lieve Vrouwe Gasthuis location East

Amsterdam, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Haga Hospital Els Borst

The Hague, Netherlands

Location

1st Military Institute of Medicine

Lublin, Poland

Location

Heliodors Święcicki Clinical Univeristy Hospital, Ul

Poznan, Poland

Location

Hospital General Universitario de Ciudad Real (HGUCR)

Ciudad Real, Spain

Location

Hospital Universitario Lucus Augusti (HULA)

Lugo, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Marqués de Valdecilla (HUMV)

Santander, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Hospital Alvaro Cunqueiro-University Hospital of Vigo

Vigo, Spain

Location

Hospital Universitario de Araba

Vitoria-Gasteiz, Spain

Location

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Location

University Hospitals Birmingham

Birmingham, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, United Kingdom

Location

Related Publications (17)

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• 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.

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  PMID: 36054266 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 19, 2021
• Study Start: November 16, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

BA (5); ES (8); NL (5); BR (5); TH (1); MY (2); PL (2); IT (14); FR (6); GB (4)