Study Comparing the MiStent SES Versus the XIENCE EES Stent
NCT ID: NCT02385279
Last Updated: 2023-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1398 participants
INTERVENTIONAL
2015-03-20
2021-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
MiStent
Percutaneous Coronary Intervention
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.
XIENCE EES
Percutaneous Coronary Intervention
Interventions
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MiStent
Percutaneous Coronary Intervention
XIENCE EES
Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* 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 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 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.
18 Years
ALL
No
Sponsors
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Micell Technologies
INDUSTRY
Stentys
INDUSTRY
ECRI bv
INDUSTRY
Responsible Party
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Principal Investigators
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Ernest Spitzer, MD
Role: STUDY_DIRECTOR
European Cardiovascular Research Institute
Locations
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Research Center Corbeil
Corbeil, , France
Research Center Nimes
Nîmes, , France
Research Center Poitiers
Poitiers, , France
Research Center Jena
Jena, , Germany
Research Center Leipzig
Leipzig, , Germany
Research Center Munster
Münster, , Germany
Research Center Ulm
Ulm, , Germany
Research Center Wiesbaden
Wiesbaden, , Germany
Research Center Amersfoort
Amersfoort, , Netherlands
Research Center Amsterdam
Amsterdam, , Netherlands
Tergooi
Blaricum, , Netherlands
Research Center Emmen
Emmen, , Netherlands
Research Center Leeuwarden
Leeuwarden, , Netherlands
Research Center Nijmegen
Nijmegen, , Netherlands
Research Center Venlo
Venlo, , Netherlands
Research Center Belchatow
Bełchatów, , Poland
Research Center Bielsko-Biala
Bielsko-Biala, , Poland
Research center Chrzanow
Chrzanów, , Poland
Research Center Tychy
Tychy, , Poland
Research Center Zgierz
Zgierz, , Poland
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ECRI-005
Identifier Type: -
Identifier Source: org_study_id
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