BIOFLOW-III Israel Satellite Registry

Launched by BIOTRONIK ISRAEL · Jul 5, 2013

Keywords

ClinConnect Summary

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 conse...

Gender

ALL

Eligibility criteria

• 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-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.