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

ECRI bv20 sites in 4 countries1,398 target enrollmentMarch 20, 2015

ConditionsCoronary Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Stenosis
Sponsor: ECRI bv
Enrollment: 1398
Locations: 20
Primary Endpoint: Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

Registry

clinicaltrials.gov

Start Date

March 20, 2015

End Date

February 4, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ECRI bv

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All comers" patients:
•Male or female patients 18 years or older;
•Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
•The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
•The patient is judged to be capable of providing voluntary informed consent and has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion Criteria

•Known pregnancy or breastfeeding at time of randomization;
•Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
•Concurrent medical condition with a life expectancy of less than 12 months.
•The patient is unwilling/ not able to return for outpatient clinic at 1 month and 12 months follow-up.
•Currently participating in another trial and not yet at its primary endpoint.

Outcomes

Primary Outcomes

Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)

Time Frame: 12 months postprocedure

DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.