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Trial of MiStent Compared to Xience in Japan

NCT02972671 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-04

No results posted yet for this study

Summary

To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population and to confirm that the domestic extrapolation of the DESSOLVE III study results is valid.

Conditions

  • Coronary (Artery); Disease

Interventions

DEVICE

MiStent (MT005) Coronary Artery Stent

Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions

DEVICE

Xience Coronary Artery Stent

Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions

Sponsors & Collaborators

  • Cardialysis BV

    collaborator INDUSTRY

  • ClinLogix. LLC

    collaborator INDUSTRY

  • Micell Technologies

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2018-04-30
Completion
2022-04-30

Countries

  • Japan

Study Locations

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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 NCT02972671 on ClinicalTrials.gov