Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.
MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster) drug eluting stent (test) and Kaname bare metal stent (comparator).
Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3 years.
500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio, to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in Kaname arm)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultimaster, Drug Eluting Stent | Experimental | Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster |
|
| Kaname, Bare metal stent | Active Comparator | Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI in patients with ST-elevation myocardial infarction | Device | Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | Composite of cardiac death, target vessel myocardial infarction, target lesion revascularization 2. Target vessel failure (TVF) Comosite of cardiac death, target vessel myocardial infarction, target lesion revascularization | 1 month, 6 months, 12 months, 2 and 3 years |
| Target vessel failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Borovicanin, MD | Terumo Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese | São Paulo | Brazil | ||||
| Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PCI in patients with ST-elevation myocardial infarction | Device | Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction |
|
|
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization |
| 1 month, 6 months, 2 and 3 years |
| Stent thrombosis | Thrombosis in study stents | 1 month, 6 months, 12 months, 2 and 3 years |
| Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization | Composite of any death, any myocardial infarction, any coronary revascularization | 1 month, 6 months, 12 months, 2 and 3 years |
| Target lesion revascularization | revascularization of treated lesion | 1 month, 6 months, 12 months, 2 and 3 years |
| Bleeding | Access or non access site bleeding | 1 month, 6 months, 12 months, 2 and 3 years |
| Safety - revascularization, stroke, definite stent thrombosis or major bleeding | revascularization, stroke, definite stent thrombosis or major bleeding at 1 month | 1 month |
| In-Stent late loss | angiographic assessment of late loss at 6 months | 6-mnths |
| Catania |
| Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| Cardiologico Monzino | Milan | Italy |
| San Raffaele Hospital | Milan | Italy |
| PHE University Cardiology clinic | Skopje | 1000 | North Macedonia |
| Clinical Center of Serbia | Belgrade | Serbia |
| Clinical Hospital Center Zemun (CHC Zemun) | Belgrade | Serbia |
| Clinical center Nis (CCNIs) | Niš | Serbia |
| Complejo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Hospital Universitario Virgen Arrixaca-Murcia | El Palmar | Spain |
| Hospital Universitario Central Asturias-Oviedo | Oviedo | Spain |
| Complejo Hospitalario Universitario Santiago de Compostela | Santiago de Compostela | Spain |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided