Study Comparing the MiStent SES Versus the XIENCE EES Stent

Coronary Stenosis Clinical Trial

— DESSOLVE III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385279
• Other study ID #: ECRI-005
• Status: Completed
• Phase: N/A
• Start date: March 20, 2015
• Est. completion date: February 4, 2021

Study information

• Verified date: July 2022
• Source: ECRI bv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1398
• Est. completion date: February 4, 2021
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• MiStent
Percutaneous Coronary Intervention
• XIENCE EES
Percutaneous Coronary Intervention

Locations

Country	Name	City	State
France	Research Center Corbeil	Corbeil
France	Research Center Nimes	Nimes
France	Research Center Poitiers	Poitiers
Germany	Research Center Jena	Jena
Germany	Research Center Leipzig	Leipzig
Germany	Research Center Munster	Munster
Germany	Research Center Ulm	Ulm
Germany	Research Center Wiesbaden	Wiesbaden
Netherlands	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
Poland	Research Center Belchatow	Belchatow
Poland	Research Center Bielsko-Biala	Bielsko-Biala
Poland	Research center Chrzanow	Chrzanow
Poland	Research Center Tychy	Tychy
Poland	Research Center Zgierz	Zgierz

Sponsors (3)

Lead Sponsor	Collaborator
ECRI bv	Micell Technologies, Stentys

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Poland, 

References & Publications (1)

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. — View Citation

Outcome

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