BIOFLOW-III All-comers Orsiro Safety and Performance Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Coronary Artery Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||BIOTRONIK - Safety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III|
- Target Lesion Failure (TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularization (TLR)
- Target Lesion Failure (TLF) [ Time Frame: 6, 36 and 60 months ] [ Designated as safety issue: Yes ]
- Target Vessel Revascularization (TVR) [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]Any repeat revascularization of the target vessel.
- Target Lesion Revascularization (TLR) [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]Any repeat revascularization of the target lesion.
- Stent Thrombosis [ Time Frame: 6, 12, 36 and 60 months ] [ Designated as safety issue: Yes ]
- Clinical Device Success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
- Clinical Procedural Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||June 2017|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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 consequences.
Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in de novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20%-40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilised on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to BMS with systemic drug administration.
These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. This observational registry is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553526
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|Study Director:||Esther Gerteis||Biotronik AG|
|Principal Investigator:||Johannes Waltenberger, Prof.||University Hospital Muenster|