Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02828683
Study type Interventional
Source Terumo Europe N.V.
Contact
Status Completed
Phase N/A
Start date July 2013
Completion date May 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06435728 - Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
Completed NCT02914795 - Platelet Function in Resuscitated Patients
Recruiting NCT00697021 - Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance Phase 3
Completed NCT05949515 - Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
Completed NCT01986803 - ABSORB STEMI: the TROFI II Study N/A
Active, not recruiting NCT01878344 - Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention Phase 3
Withdrawn NCT02048085 - Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis Phase 4
Completed NCT04463251 - Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction Phase 2
Active, not recruiting NCT02943954 - FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction N/A
Completed NCT02298088 - Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis Phase 3
Active, not recruiting NCT02067091 - Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct Phase 3
Completed NCT01787110 - An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction Phase 3
Recruiting NCT03137212 - Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time N/A
Not yet recruiting NCT05802667 - A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Completed NCT04730778 - Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients