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

July 12, 2022 updated by: ECRI bv

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: MiStent
Percutaneous Coronary Intervention
Active Comparator: 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.
Device: XIENCE EES
Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months postprocedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECRI bv

Collaborators

Micell Technologies
Stentys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2015

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRI-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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