BIOFLOW-III Sweden Satellite Registry
|ClinicalTrials.gov Identifier: NCT01667003|
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : September 28, 2017
|Condition or disease|
|Coronary Artery Disease Myocardial Ischemia|
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.
|Study Type :||Observational|
|Actual Enrollment :||406 participants|
|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 Sweden|
|Actual Study Start Date :||August 2012|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2015|
- Target Lesion Failure (TLF) [ Time Frame: 12 months ]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 and 12 months ]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 Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ]Any repeat revascularization of the target vessel.
- Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ]Any repeat revascularization of the target lesion.
- Stent Thrombosis [ Time Frame: 6 and 12 months ]Definite, Probable, Possible Stent thrombosis
- Clinical Device Success [ Time Frame: At time of intervention ]Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy. Standard predilation catheters and post-dilation catheters (if applicable) may be used.
- Clinical Procedural Success [ Time Frame: During the hospital stay to a maximum of the first seven days post index procedure ]Successful delivery and deployment of the investigational stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple overlapping stents, if applicable) and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% of the target lesion as observed by visual estimate without using any adjunctive device* without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of the first seven days post index procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667003
|Centralsjukhuset i Karlstad|
|Stockholm, Sweden, 11883|
|Danderyd University Hospital|
|Karolinska University Hospitals (Huddinge/Solna)|
|Örebro, Sweden, 701 85|
|Principal Investigator:||Ole Froebert, MD||Kardiologiska Kliniken|