BIOFLOW-III All-comers Orsiro Safety and Performance Registry

Launched by BIOTRONIK AG · Mar 12, 2012

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:
• • Symptomatic coronary artery disease
• • Subject has signed informed consent for data release
• • Subject is geographically stable and willing to participate at all follow-up assessments
• • Subject is ≥ 18 years
• Exclusion Criteria:
• • Subject did not sign informed consent for data release
• • Pregnancy
• • Known 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.