Study Comparing the MiStent SES Versus the XIENCE EES Stent

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: MiStent
* Device: XIENCE EES


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiStent®<br>Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. | Device: MiStent<br>* Percutaneous Coronary Intervention<br>|
| Active Comparator: XIENCE EES<br>Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. | Device: XIENCE EES<br>* Percutaneous Coronary Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | 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. | 12 months postprocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POCE | POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization | At 12 months | 
| MACE | MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) | At 12 months | 
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR | At 12 months | 
| All-cause Death | All-cause death | At 12 months | 
| Myocardial Infarction | Any Myocardial infarction | At 12 months | 
| Any Revascularization | Any revascularization | At 12 months | 
| Stent Thrombosis | Definite or probably stent thrombosis according to ARC | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD, ACS, All comers, PCI