NCT02972671

Trial of MiStent Compared to Xience in Japan

Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Micell Technologies · Industry
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE 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.

Conditions

• Coronary (Artery); Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-28
• Primary completion: 2018-04-30
• Completion: 2022-04-30
• First posted: 2016-11-23
• Last updated: 2020-09-04

Locations

10 sites across 1 country: Japan