Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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).
Eligibility
Primary outcome measure(s)
- Number of target Lesion Failure (TLF) at 12 Months — 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. - Number of NACEs — 12 Months
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.
Trial sites (53)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
+ 13 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04893291 on ClinicalTrials.gov ↗ ← All trials in Italy