Status:
COMPLETED
BIOFLOW-III Israel Satellite Registry
Lead Sponsor:
BIOTRONIK Israel
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
Detailed Description
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 compl...
Eligibility Criteria
Inclusion
- 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
- 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-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. 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.
- Other medical illness (e.g, cancer or congestive heart failure) or Known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01895712
Start Date
August 1 2013
End Date
June 1 2015
Last Update
September 28 2017
Active Locations (6)
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1
Rambam medical Center
Haifa, Israel, 31096
2
Carmel medical Center
Haifa, Israel, 34362
3
Hadassah medical Center
Jerusalem, Israel, 91120
4
Meir medical Center
Kfar Saba, Israel, 44410