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ACTIVE NOT RECRUITING
NCT04893291
NA

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

Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1820

Start Date

2021-11-16

Completion Date

2030-08-30

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

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

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

Locations (53)

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