BIOFLOW-III Israel Satellite Registry (NCT01895712) | Clinical Trial Compass
CompletedNot Applicable
BIOFLOW-III Israel Satellite Registry
Israel120 participantsStarted 2013-08
Plain-language summary
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with diabetes mellitus Type 1 or 2
* Stable coronary patients with moderate-severe symptomatic angina (CCS ≥II) and evidence of myocardial ischemia per non- invasive test (nuclear or echo) or patients with 'silent' myocardial ischemia and a large (e.g. \>10% of myocardium) territory of myocardium in jeopardy (nuclear or echo)
* Subject signed informed consent
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age
Exclusion Criteria:
* Subject did not sign informed consent
* Left main disease
* Complex bifurcations
* Ostial lesions
* Three vessel disease
* Large visible thrombus
* Heavy calcified lesions needing atherectomy or cutting balloon dilatation
* Syntax Score ≥33
* Active bleeding
* Sepsis
* Chronic total Occlusion
* Bleeding tendency obviate dual anti platelet (DAP) intake for one year
* Hb\<11/Plts,100.000/WBC\<4000 or \>11.00
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child- bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
* Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), sirolimus, poly (L-lactide) poly (DL-lac…