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This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orsiro DES |
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| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 6, 36 and 60 months | |
| Target Vessel Revascularization (TVR) | Any repeat revascularization of the target vessel. | 6, 12, 36 and 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
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| Name | Affiliation | Role |
|---|---|---|
| Esther Gerteis | Biotronik AG | Study Director |
| Johannes Waltenberger, Prof. | University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Innsbruck | Innsbruck | 6020 | Austria | |||
| Clinica Tabancura |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32890442 | Derived | 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. | |
| 30922870 |
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| Target Lesion Revascularization (TLR) | Any repeat revascularization of the target lesion. | 6, 12, 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 |
| Santiago |
| Vitacura |
| Chile |
| Gentofte Universitets Hospital | Hellerup | 2900 | Denmark |
| Clinique Rhone Durance | Avignon | 84082 | France |
| CHU Bocage Dijon | Dijon | 21034 | France |
| CCML Le Plessis Robinson | Le Plessis-Robinson | 92350 | France |
| CHRU Brabois Nancy | Nancy | 54500 | France |
| CH Niort | Niort | 79000 | France |
| Clinique Saint Hilaire Rouen | Rouen | 76000 | France |
| CHRU Rangueil Toulouse | Toulouse | 31403 | France |
| CHG Troyes | Troyes | 10003 | France |
| CH Valence | Valence | 26953 | France |
| Segeberger Kliniken | Bad Segeberg | 23795 | Germany |
| Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Kardiologisch-Angiologische Praxis Hegeler | Bremen | 28277 | Germany |
| Klinikum Coburg | Coburg | 96450 | Germany |
| Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I | Halle | 06120 | Germany |
| Asklepiosklinik St. Georg | Hamburg | 20099 | Germany |
| Uniklinik Heidelberg, Medizinische Uniklinik | Heidelberg | 69120 | Germany |
| Klinikum Landshut-Achdorf Medizinische Klinik I | Landshut | 84036 | Germany |
| University of Leipzig | Leipzig | 04103 | Germany |
| LMU-Großhadern | Munich | 81377 | Germany |
| HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin | Munich | 81925 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Uniklink Regensburg | Regensburg | 93053 | Germany |
| Kliniken Villingen - Kardiologie | Villingen-Schwenningen | 78050 | Germany |
| Centro cardiologico Monzino | Milan | Italy |
| Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata | Rome | 00133 | Italy |
| Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Riga Eastern Clinical University Hospital | Riga | 1038 | Latvia |
| VU Medical Center HV Amsterdam | Amsterdam | 1081 HV | Netherlands |
| Alysis Hospital | Arnhem | 6815 AD | Netherlands |
| Amphia Ziekenhuis Breda | Breda | 4818 CK | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| ZorgSaam Terneuzen | Terneuzen | 4535 PA | Netherlands |
| Twee Steden Hospital Tilburg | Tilburg | 5042 AD | Netherlands |
| Centro Hospitalar de Coimbra | São Martinho do Bispo | 3041-801 | Portugal |
| Hospital de Navarra | Pamplona | 31008 | Spain |
| Universitetssjukhuset Oerebro, Kardiologiska Kliniken | Örebro | 701 85 | Sweden |
| Clinique Cecil | Lausanne | 1003 | Switzerland |
| Kantonsspital Liestal | Liestal | 4410 | Switzerland |
| Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland | Belfast | BT63 5QQ | United Kingdom |
| The Heart Hospital, UCLH | London | W1G 8PH | United Kingdom |
| Derived |
| 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. |
| 25782184 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D007511 | Ischemia |
| D000787 | Angina Pectoris |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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