BIOFLOW-III All-comers Orsiro Safety and Performance Registry
NCT ID: NCT01553526
Last Updated: 2016-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1356 participants
OBSERVATIONAL
2011-08-31
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Orsiro DES
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Esther Gerteis
Role: STUDY_DIRECTOR
Biotronik AG
Johannes Waltenberger, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Muenster
Locations
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University Hospital Innsbruck
Innsbruck, , Austria
Clinica Tabancura
Santiago, , Chile
Gentofte Universitets Hospital
Hellerup, , Denmark
Clinique Rhone Durance
Avignon, , France
CHU Bocage Dijon
Dijon, , France
CCML Le Plessis Robinson
Le Plessis-Robinson, , France
CHRU Brabois Nancy
Nancy, , France
CH Niort
Niort, , France
Clinique Saint Hilaire Rouen
Rouen, , France
CHRU Rangueil Toulouse
Toulouse, , France
CHG Troyes
Troyes, , France
CH Valence
Valence, , France
Segeberger Kliniken
Bad Segeberg, , Germany
Klinikum im Friedrichshain
Berlin, , Germany
Kardiologisch-Angiologische Praxis Hegeler
Bremen, , Germany
Klinikum Coburg
Coburg, , Germany
Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I
Halle, , Germany
Asklepiosklinik St. Georg
Hamburg, , Germany
Uniklinik Heidelberg, Medizinische Uniklinik
Heidelberg, , Germany
Klinikum Landshut-Achdorf Medizinische Klinik I
Landshut, , Germany
University of Leipzig
Leipzig, , Germany
LMU-Großhadern
Munich, , Germany
HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin
Munich, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Uniklink Regensburg
Regensburg, , Germany
Kliniken Villingen - Kardiologie
Villingen-Schwenningen, , Germany
Centro cardiologico Monzino
Milan, , Italy
Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata
Rome, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga Eastern Clinical University Hospital
Riga, , Latvia
VU Medical Center HV Amsterdam
Amsterdam, , Netherlands
Alysis Hospital
Arnhem, , Netherlands
Amphia Ziekenhuis Breda
Breda, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
ZorgSaam Terneuzen
Terneuzen, , Netherlands
Twee Steden Hospital Tilburg
Tilburg, , Netherlands
Centro Hospitalar de Coimbra
São Martinho do Bispo, , Portugal
Hospital de Navarra
Pamplona, , Spain
Universitetssjukhuset Oerebro, Kardiologiska Kliniken
Örebro, , Sweden
Clinique Cecil
Lausanne, , Switzerland
Kantonsspital Liestal
Liestal, , Switzerland
Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland
Belfast, , United Kingdom
The Heart Hospital, UCLH
London, , United Kingdom
Countries
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References
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Toelg R, Slagboom T, Waltenberger J, Lefevre T, Saito S, Kandzari DE, Koolen J, Richardt G. Individual patient data analysis of the BIOFLOW study program comparing safety and efficacy of a bioresorbable polymer sirolimus eluting stent to a durable polymer everolimus eluting stent. Catheter Cardiovasc Interv. 2021 Nov 1;98(5):848-856. doi: 10.1002/ccd.29254. Epub 2020 Sep 5.
Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Friedrich G, Erglis A, Winkens M, Hegeler-Molkewehrum C, Neef M, Hoffmann S; BIOFLOW-III Investigators. Five-Year Results of the Bioflow-III Registry: Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent. Cardiovasc Revasc Med. 2020 Jan;21(1):63-69. doi: 10.1016/j.carrev.2019.03.004. Epub 2019 Mar 15.
Waltenberger J, Brachmann J, van der Heyden J, Richardt G, Frobert O, Seige M, Erglis A, Dewilde W, Winkens M, Hegeler-Molkewehrum C, Klein N, Hoffmann S; BIOFLOW-III Investigators. Real-world experience with a novel biodegradable polymer sirolimus-eluting stent: twelve-month results of the BIOFLOW-III registry. EuroIntervention. 2016 Feb;11(10):1106-10. doi: 10.4244/EIJY15M03_08.
Other Identifiers
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C1101
Identifier Type: -
Identifier Source: org_study_id
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