BIOFLOW-III Belgium Satellite 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 Belgium|
- 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 Vessel Revascularization (TVR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]Any repeat revascularization of the target vessel.
- Target Lesion Revascularization (TLR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]Any repeat revascularization of the target lesion.
- Stent Thrombosis [ Time Frame: 6 and 12 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 ]
- Target Lesion Failure (TLF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||September 2014 (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: NCT01831336
|Contact: Monique Schaefer||+ 32 498 firstname.lastname@example.org|
|Brussels Heart Center||Recruiting|
|Contact: Steven Vercauteren, Dr email@example.com|
|Principal Investigator: Steven Vercauteren, Dr|
|Contact: Jacques Lalmand, Dr firstname.lastname@example.org|
|Principal Investigator: Jacques Lalmand, Dr|
|Grand Hopital de Charleroi Saint Joseph||Recruiting|
|Contact: Stephane Fasseaux email@example.com|
|Principal Investigator: Stephane Fasseaux, Dr|
|CHU Liège||Not yet recruiting|
|Contact: Victor Legrand, Prof Dr vlegrand@chu_ulg.ac.be|
|Principal Investigator: Victor Legrand, Prof. Dr.|
|CHR de la Citadelle||Active, not recruiting|
|Brussels Heart Center St Pierre||Not yet recruiting|
|Contact: Francois Cardinal firstname.lastname@example.org|
|Principal Investigator: Francois Cardinal, Dr|
|UCL de Mont Godine||Not yet recruiting|
|Contact: Erwin Schroeder, Dr Prof|
|Principal Investigator: Erwin Schroeder, Prof Dr|
|Principal Investigator:||Victor Legrand, Prof. Dr.||CHU Liege (Hospitalo-Facultaire Universitaire de Liège)|