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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02385279 |
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Date of registration:
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17/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Comparing the MiStent SES Versus the XIENCE EES Stent
DESSOLVE III |
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Scientific title:
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Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries |
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Date of first enrolment:
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March 20, 2015 |
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Target sample size:
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1404 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02385279 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Netherlands
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Poland
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Contacts
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Name:
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P. W. Serruys, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom |
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Name:
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W Wijns, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hartcenter, OLV Aalst, Belgium |
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Name:
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R. de Winter, Prof. MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academisch Medisch Centrum, Amsterdam, The Netherlands |
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Name:
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Gerrit-Anne van Es |
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Address:
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Telephone:
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Email:
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Affiliation:
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ECRI bv |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Stenosis
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Intervention(s)
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Device: MiStent
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Device: XIENCE EES
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Primary Outcome(s)
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Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the MISTENT group to the XIENCE group
[Time Frame: 12 months postprocedure]
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Secondary Outcome(s)
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MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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Mortality
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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DOCE/TLF defined as cardiac death, TV MI or clinically indicated Target Lesion Revascularization (TLR)
[Time Frame: 30 days, 6 months, 2 years, 3 years]
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Myocardial infarction
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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Revascularization
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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Stent thrombosis rates according to ARC classification
[Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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