Coronary Artery Diseases Clinical Trial
Official title:
BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III United Kingdom Satellite
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal
Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to
long-term complications range from rather immediate elastic coil or vessel contraction to
longer processes like smooth muscle cell proliferation and excessive production of extra
cellular matrix, thrombus formation and atherosclerotic changes like restenosis or
angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to
50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS),
designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis
rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS
substantially reduced the incidence of abrupt artery closure, but restenosis still occurred
in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by
adding an antiproliferative drug (directly immobilized on the stent surface or released from
a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly
reduced the incidence of restenosis and resulted in better safety profile as compared to BMS
with systemic drug administration. These advantages and a lower cost compared to surgical
interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the
ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and
collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting
Stent System in an all-comers patient population in daily clinical practice.
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