Study Comparing the MiStent SES Versus the XIENCE EES Stent

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MiStent®	MiStent	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.
XIENCE EES	XIENCE EES	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)	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.

Secondary Outcome Measures

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

Locations (20): Research Center Ulm
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Ulm, Germany
Research Center Munster
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Munster, Germany
Research Center Tychy
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Tychy, Poland
Research Center Amersfoort
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Amersfoort, Netherlands
Tergooi
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Blaricum, Netherlands
Research Center Nijmegen
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Nijmegen, Netherlands
Research Center Belchatow
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Belchatow, Poland
Research Center Bielsko-Biala
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Bielsko-Biala, Poland
Research Center Zgierz
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Zgierz, Poland
Research Center Corbeil
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Corbeil, France
Research Center Nimes
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Nimes, France
Research Center Poitiers
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Poitiers, France
Research Center Jena
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Jena, Germany
Research Center Amsterdam
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Amsterdam, Netherlands
Research Center Emmen
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Emmen, Netherlands
Research Center Leeuwarden
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Leeuwarden, Netherlands
Research Center Venlo
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Venlo, Netherlands
Research center Chrzanow
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Chrzanow, Poland
Research Center Leipzig
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Leipzig, Germany
Research Center Wiesbaden
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Wiesbaden, Germany