Late Acquired Stent Malaposition
Conditions
Brief summary
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
Detailed description
please see brief summary
Interventions
PROCEDUREEverolimus-Eluting Stent (EES)
Patients treated with EES
PROCEDUREZotarolimus-Eluting-Stent (ZES)
Patients treated with ZES
PROCEDUREBiolimus-Eluting-Stent (BES)
Patients treated with BES
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who underwent an elective treatment of a coronary lesion \> 20mm with a DES
Exclusion criteria
* chronic renal failure (serum creatinine ≥ 2.5mg/dl) * restenotic lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of stent struts with late acquired malaposition | 1 year after stent implantation |
Secondary
| Measure | Time frame |
|---|---|
| number of stent struts with late acquired malaposition | 2 years after stent implantation |
Countries
Austria
Outcome results
None listed