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OpenTrials
Completed

NCT Number: NCT02385279

Study Comparing the MiStent SES Versus the XIENCE EES Stent

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Center Corbeil, Corbeil, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MiStent

Device

Percutaneous Coronary Intervention

XIENCE EES

Device

Percutaneous Coronary Intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. POCE

    Time frame: At 12 months

    POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization

  2. MACE

    Time frame: At 12 months

    MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)

  3. Target Vessel Failure (TVF)

    Time frame: At 12 months

    Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR

  4. All-cause Death

    Time frame: At 12 months

    All-cause death

  5. Myocardial Infarction

    Time frame: At 12 months

    Any Myocardial infarction

  6. Any Revascularization

    Time frame: At 12 months

    Any revascularization

  7. Stent Thrombosis

    Time frame: At 12 months

    Definite or probably stent thrombosis according to ARC

Sponsors and collaborators

Lead sponsor

ECRI bv

Industry

Collaborators

  • Micell Technologies
  • Stentys

Registry information

Official study title

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

Acronym: DESSOLVE III

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Mar 11, 2015
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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