Coronary Artery Disease Clinical Trial
Official title:
Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease
The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
Current treatments for coronary artery disease include conservative treatment (drug
therapies) and invasive techniques that help increase blood flow to ischemic or
oxygen-deprived regions of the heart. Among the invasive techniques the most frequently used
are coronary artery bypass graft surgery (CABG), and percutaneous transluminal coronary
angioplasty (PTCA) without or with stents (bare metal stents (BMS) or drug eluting stents
(DES)) implantation. However, all of those treatments have limitations and their
effectiveness is diminished under certain circumstances. Therefore, it is essential to tailor
therapy for each individual patient considering the overall patient's condition, disease
severity and progression as well as concomitant diseases. The question of selection of
appropriate stent for each individual patient is still unresolved and most of the physicians
either follow international or national guidelines or scientific wisdom.
Although the efficacy of DES is undisputable in restenosis prevention, because some patients
could have adverse outcomes from a DES, they should be used selectively in those who are most
likely to benefit, and in that decision process several important issues should be addressed
such as:Patients' adherence to post-stenting therapy, Bleeding risk, Need for elective
surgery, Risk for restenosis, Risk for stent thrombosis. It is still believed that many
patients will do well with BMSs and that this technology requires further refinements to
improve outcome. For the above reasons Terumo has designed the new coronary BMS, Kanameā¢, a
balloon expandable Cobalt-Chromium (CoCr) stent pre-mounted onto a high pressure,
semi-compliant balloon on a rapid exchange delivery catheter. The Kaname stent is the subject
of the current prospective, multi-centre KARE study.
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