N/A
N=1,398
Study Comparing the MiStent SES Versus the XIENCE EES Stent
Coronary Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT02385279 ↗Enrolled (actual)
1,398
Serious AEs
61.5%
Results posted
May 2023
Primary outcome: Primary: Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) — 40; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MiStent (Device); XIENCE EES (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ECRI bv
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) |
40; 45 | — |
| SECONDARY POCE |
93; 101 | — |
| SECONDARY MACE |
65; 65 | — |
| SECONDARY Target Vessel Failure (TVF) |
45; 53 | — |
| SECONDARY All-cause Death |
25; 18 | — |
| SECONDARY Myocardial Infarction |
17; 15 | — |
| SECONDARY Any Revascularization |
61; 78 | — |
| SECONDARY Stent Thrombosis |
5; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02385279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.