MedTrace Logo

Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

NCT02828683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

  • Acute ST Segment Elevation Myocardial Infarction

Interventions

DEVICE

PCI in patients with ST-elevation myocardial infarction

Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)

DEVICE

PCI in patients with ST-elevation myocardial infarction

Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Vladimir Borovicanin, MD · Terumo Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-07-31
Completion
2018-05-31

Countries

  • Brazil
  • Italy
  • North Macedonia
  • Serbia
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828683 on ClinicalTrials.gov