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

Primary Purpose

Coronary Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MiStent
XIENCE EES
Sponsored by
ECRI bv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis focused on measuring CAD, ACS, All comers, PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MiStent®

XIENCE EES

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2015
Last Updated
July 12, 2022
Sponsor
ECRI bv
Collaborators
Micell Technologies, Stentys
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1. Study Identification

Unique Protocol Identification Number
NCT02385279
Brief Title
Study Comparing the MiStent SES Versus the XIENCE EES Stent
Acronym
DESSOLVE III
Official Title
Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECRI bv
Collaborators
Micell Technologies, Stentys

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
CAD, ACS, All comers, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiStent®
Arm Type
Experimental
Arm 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.
Arm Title
XIENCE EES
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
MiStent
Intervention Description
Percutaneous Coronary Intervention
Intervention Type
Device
Intervention Name(s)
XIENCE EES
Intervention Description
Percutaneous Coronary Intervention
Primary Outcome Measure Information:
Title
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
Description
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.
Time Frame
12 months postprocedure
Secondary Outcome Measure Information:
Title
POCE
Description
POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
Time Frame
At 12 months
Title
MACE
Description
MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
Time Frame
At 12 months
Title
Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
Time Frame
At 12 months
Title
All-cause Death
Description
All-cause death
Time Frame
At 12 months
Title
Myocardial Infarction
Description
Any Myocardial infarction
Time Frame
At 12 months
Title
Any Revascularization
Description
Any revascularization
Time Frame
At 12 months
Title
Stent Thrombosis
Description
Definite or probably stent thrombosis according to ARC
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest Spitzer, MD
Organizational Affiliation
European Cardiovascular Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Research Center Corbeil
City
Corbeil
Country
France
Facility Name
Research Center Nimes
City
Nimes
Country
France
Facility Name
Research Center Poitiers
City
Poitiers
Country
France
Facility Name
Research Center Jena
City
Jena
Country
Germany
Facility Name
Research Center Leipzig
City
Leipzig
Country
Germany
Facility Name
Research Center Munster
City
Munster
Country
Germany
Facility Name
Research Center Ulm
City
Ulm
Country
Germany
Facility Name
Research Center Wiesbaden
City
Wiesbaden
Country
Germany
Facility Name
Research Center Amersfoort
City
Amersfoort
Country
Netherlands
Facility Name
Research Center Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Tergooi
City
Blaricum
Country
Netherlands
Facility Name
Research Center Emmen
City
Emmen
Country
Netherlands
Facility Name
Research Center Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
Research Center Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Research Center Venlo
City
Venlo
Country
Netherlands
Facility Name
Research Center Belchatow
City
Belchatow
Country
Poland
Facility Name
Research Center Bielsko-Biala
City
Bielsko-Biala
Country
Poland
Facility Name
Research center Chrzanow
City
Chrzanow
Country
Poland
Facility Name
Research Center Tychy
City
Tychy
Country
Poland
Facility Name
Research Center Zgierz
City
Zgierz
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29203070
Citation
de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wohrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Zurakowski A, Fischer D, Kosmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5.
Results Reference
background
PubMed Identifier
34666500
Citation
Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.
Results Reference
derived
PubMed Identifier
32888011
Citation
Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172.
Results Reference
derived
PubMed Identifier
32466676
Citation
Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29.
Results Reference
derived

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Study Comparing the MiStent SES Versus the XIENCE EES Stent

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