BIOFLOW-III All-comers Orsiro Safety and Performance Registry
- Conditions
- Coronary Artery DiseaseMyocardial Ischemia
- Registration Number
- NCT01553526
- Lead Sponsor
- Biotronik AG
- Brief Summary
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1356
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) 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)
- Secondary Outcome Measures
Name Time Method Target Lesion Failure (TLF) 6, 36 and 60 months Stent Thrombosis 6, 12, 36 and 60 months Clinical Device Success At time of intervention Clinical Procedural Success During the hospital stay to a maximum of the first seven days post index procedure Target Vessel Revascularization (TVR) 6, 12, 36 and 60 months Any repeat revascularization of the target vessel.
Target Lesion Revascularization (TLR) 6, 12, 36 and 60 months Any repeat revascularization of the target lesion.
Trial Locations
- Locations (43)
CH Valence
🇫🇷Valence, France
Segeberger Kliniken
🇩🇪Bad Segeberg, Germany
CHU Bocage Dijon
🇫🇷Dijon, France
CCML Le Plessis Robinson
🇫🇷Le Plessis Robinson, France
CHRU Brabois Nancy
🇫🇷Nancy, France
CH Niort
🇫🇷Niort, France
Clinique Rhone Durance
🇫🇷Avignon, France
Kardiologisch-Angiologische Praxis Hegeler
🇩🇪Bremen, Germany
Hospital de Navarra
🇪🇸Pamplona, Spain
HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin
🇩🇪Munich, Germany
Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland
🇬🇧Belfast, United Kingdom
Clinique Saint Hilaire Rouen
🇫🇷Rouen, France
University of Leipzig
🇩🇪Leipzig, Germany
Uniklink Regensburg
🇩🇪Regensburg, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Kliniken Villingen - Kardiologie
🇩🇪Villingen-Schwenningen, Germany
CHRU Rangueil Toulouse
🇫🇷Toulouse, France
LMU-Großhadern
🇩🇪Munich, Germany
Asklepiosklinik St. Georg
🇩🇪Hamburg, Germany
Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I
🇩🇪Halle, Germany
Universitetssjukhuset Oerebro, Kardiologiska Kliniken
🇸🇪Oerebro, Sweden
The Heart Hospital, UCLH
🇬🇧London, United Kingdom
Centro cardiologico Monzino
🇮🇹Milano, Italy
Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata
🇮🇹Rome, Italy
Gentofte Universitets Hospital
🇩🇰Hellerup, Denmark
CHG Troyes
🇫🇷Troyes, France
Clinica Tabancura
🇨🇱Santiago, Chile
Riga Eastern Clinical University Hospital
🇱🇻Riga, Latvia
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
VU Medical Center HV Amsterdam
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis Breda
🇳🇱Breda, Netherlands
Clinique Cecil
🇨🇭Lausanne, Switzerland
Alysis Hospital
🇳🇱Arnhem, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Twee Steden Hospital Tilburg
🇳🇱Tilburg, Netherlands
Centro Hospitalar de Coimbra
🇵🇹Sao Martinho do Bispo, Portugal
University Hospital Innsbruck
🇦🇹Innsbruck, Austria
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
ZorgSaam Terneuzen
🇳🇱Terneuzen, Netherlands
Uniklinik Heidelberg, Medizinische Uniklinik
🇩🇪Heidelberg, Germany
Klinikum Landshut-Achdorf Medizinische Klinik I
🇩🇪Landshut, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany