BIOTRONIK - SaFety and Performance Registry for an all-comers Diabeticpatient population with the Limus Eluting Orsiro Stent System Within dailyclinical practice - III - BIOFLOW-III Asia Registry

BIOTRONIK Asia Pacific Pte Ltd0 个研究点目标入组 880 人开始时间: 待定最近更新: 2021年11月24日

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•Diabetes Mellitus:
•Known Diabetic on Pharmacological treatment.
•ACS NSTEMI with documented Hb A1c >7%, even if not on Pharmacological treatment for diabetes.
•Subject is >= 18 years of age
•Patient has Symptomatic coronary artery disease
•Target lesion must be a de novo lesion located in a native coronary artery with reference vessel
•diameter >=2.25 mm & <=4.00 mm, lesion length <=40 mm by visual estimate
•Patient should be receiving upto 3 stents and upto 2 stents per artery.
•Target lesion must be in a major coronary artery
•or branch with visually estimated stenosis >=50%
•& <100% with TIMI flow>=1.
•Subject provides signed informed consent for data release Subject is geographically stable and willing to comply with protocol required follow ups

•Pregnant and/or breast-feeding females who
•intend to become pregnant during the period of
•the registry
•Untreatable intolerance to aspirin, clopidogrel,
•ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, stainless
•steel, Sirolimus or contrast media
•Planned surgery within 6 months of PCI unless
•dual antiplatelet therapy will be maintained
•Currently participating in another study and
•primary endpoint is not reached yet.
•if the subject has a high probability that a
•procedure other than predilatation, stent
•implantation and post dilatation will be required at time of index procedure for treatment of target
•vessel (e.g. atherectomy, cutting balloon or
•brachytherapy).
•Patients admitted for treatment of Diabetic
•ketoacedosis >= 2 times in the past Six months
•(Brittle Diabetics).

发起方

BIOTRONIK Asia Pacific Pte Ltd