Coronary Artery Disease Clinical Trial
Official title:
Biotronik-Safety and Performance Registry for an All-comers Diabetic Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice-III Asia
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry. The sample subjects size may be increased in order to reach the subgroup sizes (Small Vessel and AMI).
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal
Coronary Angioplasty (PTCA) provides high initial procedural success. However, the medium to
long-term complications range from rather immediate elastic recoil 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%-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%-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 a 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.
An interesting group of analysis resulted to be diabetic patients. It has been concluded that
the incidence of both nonocclusive and occlusive restenosis is higher in diabetic subjects
after stenting as judged from comparison with historical control subjects. Results implicate
accelerated restenosis as both a consequence of diabetes and a cause for increased mortality
after PCI in diabetic patient.
Therefore this observational registry has been designed for the clinical evaluation of the
Orsiro LESS in diabetic subjects (Diabetic patients type 1 or 2) requiring coronary
revascularization with Drug Eluting Stents (DES). Results will contribute to the collection
of clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent
System in daily clinical practice.
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