Clinical trial NCT02385279: Study Comparing the MiStent SES Versus the XIENCE EES Stent
Official title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Keywords: CAD
ACS
All comers
PCI
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Micell Technologies
name: Stentys
First posted: 2015-03-11
Enrollment: 1398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
timeFrame: 12 months postprocedure
Secondary outcomes:
measure: POCE
timeFrame: At 12 months
measure: MACE
timeFrame: At 12 months
measure: Target Vessel Failure (TVF)
timeFrame: At 12 months
measure: All-cause Death
timeFrame: At 12 months
measure: Myocardial Infarction
timeFrame: At 12 months
measure: Any Revascularization
timeFrame: At 12 months
measure: Stent Thrombosis
timeFrame: At 12 months
Other outcomes:
Locations:
city: Corbeil
country: France
facility: Research Center Corbeil
city: Nimes
country: France
facility: Research Center Nimes
city: Poitiers
country: France
facility: Research Center Poitiers
city: Jena
country: Germany
facility: Research Center Jena
city: Leipzig
country: Germany
facility: Research Center Leipzig
city: Munster
country: Germany
facility: Research Center Munster
city: Ulm
country: Germany
facility: Research Center Ulm
city: Wiesbaden
country: Germany
facility: Research Center Wiesbaden
city: Amersfoort
country: Netherlands
facility: Research Center Amersfoort
city: Amsterdam
country: Netherlands
facility: Research Center Amsterdam
city: Blaricum
country: Netherlands
facility: Tergooi
city: Emmen
country: Netherlands
facility: Research Center Emmen
city: Leeuwarden
country: Netherlands
facility: Research Center Leeuwarden
city: Nijmegen
country: Netherlands
facility: Research Center Nijmegen
city: Venlo
country: Netherlands
facility: Research Center Venlo
city: Belchatow
country: Poland
facility: Research Center Belchatow
city: Bielsko-Biala
country: Poland
facility: Research Center Bielsko-Biala
city: Chrzanow
country: Poland
facility: Research center Chrzanow
city: Tychy
country: Poland
facility: Research Center Tychy
city: Zgierz
country: Poland
facility: Research Center Zgierz
Study officials:
affiliation: European Cardiovascular Research Institute
name: Ernest Spitzer, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.