Study Comparing the MiStent SES Versus the XIENCE EES Stent

NCT02385279 | Completed Results DMC

• 1 other identifier: ECRI-005
• Study Type: interventional
• Target: 1,398
• Locations: 4 countries
• Sites: 20

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.

Conditions

Coronary Stenosis

Keywords

CAD; ACS; All comers; PCI

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months postprocedure

Secondary Outcomes (7)

• POCE

  At 12 months

• MACE

  At 12 months

• Target Vessel Failure (TVF)

  At 12 months

• All-cause Death

  At 12 months

• Myocardial Infarction

  At 12 months

Study Arms (2)

MiStent®

EXPERIMENTAL

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

XIENCE EES

ACTIVE COMPARATOR

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

Interventions

MiStent DEVICE

Percutaneous Coronary Intervention

MiStent®

XIENCE EES DEVICE

Percutaneous Coronary Intervention

XIENCE EES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ECRI bv: lead
• Micell Technologies: collaborator
• Stentys: collaborator

Study Sites (20)

Research Center Corbeil

Corbeil, France

Location

Research Center Nimes

Nîmes, France

Location

Research Center Poitiers

Poitiers, France

Location

Research Center Jena

Jena, Germany

Location

Research Center Leipzig

Leipzig, Germany

Location

Research Center Munster

Münster, Germany

Location

Research Center Ulm

Ulm, Germany

Location

Research Center Wiesbaden

Wiesbaden, Germany

Location

Research Center Amersfoort

Amersfoort, Netherlands

Location

Research Center Amsterdam

Amsterdam, Netherlands

Location

Tergooi

Blaricum, Netherlands

Location

Research Center Emmen

Emmen, Netherlands

Location

Research Center Leeuwarden

Leeuwarden, Netherlands

Location

Research Center Nijmegen

Nijmegen, Netherlands

Location

Research Center Venlo

Venlo, Netherlands

Location

Research Center Belchatow

Bełchatów, Poland

Location

Research Center Bielsko-Biala

Bielsko-Biala, Poland

Location

Research center Chrzanow

Chrzanów, Poland

Location

Research Center Tychy

Tychy, Poland

Location

Research Center Zgierz

Zgierz, Poland

Location

Related Publications (4)

• 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.

  PMID: 29203070 BACKGROUND

• 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.

  PMID: 34666500 DERIVED

• 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.

  PMID: 32888011 DERIVED

• 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.

  PMID: 32466676 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. E. Spitzer
• Organization: European Cardiovascular Research Institute

E.Spitzer@ECRI-Trials.com

+31102062828

Study Officials

• Ernest Spitzer, MD

  European Cardiovascular Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 11, 2015
• Study Start: March 20, 2015
• Primary Completion: January 31, 2017
• Study Completion: February 4, 2021
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2022-07

Locations

FR (3); NL (7); PL (5); DE (5)