Study Comparing the MiStent SES Versus the XIENCE EES Stent (DESSOLVE III)

European Cardiovascular Research Institute (ECRI)

Status: Completed

Conditions: Coronary Stenosis

Treatments: Device: MiStent; Device: XIENCE EES

Study type: Interventional

Funder types: Industry

Identifiers

NCT02385279

ECRI-005

Details and patient eligibility

About

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.

Enrollment: 1,398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,398 participants in 2 patient groups

MiStent®

Experimental group

Description:

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.

Treatment:

Device: MiStent

XIENCE EES

Active Comparator group

Description:

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.

Treatment:

Device: XIENCE EES