BIOFLOW-III All-comers Orsiro Safety and Performance Registry

NCT01553526 | Unknown

• 1 other identifier: C1101
• Study Type: observational
• Target: 1,356
• Locations: 13 countries
• Sites: 43

Brief Summary

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

International; Multicenter; Observational registry; All-comers open label registry; Orsiro Drug Eluting Stent (DES); Stenting; Treatment of Coronary Artery Disease; Coronary revascularization; Percutaneous Coronary Intervention; STEMI; NSTEMI; Ischemia; Angina; Subgroups; Acute Myocardial Infarction; Diabetes; Small Vessels; Chronic Total Occlusion (CTO)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Target Lesion Failure (TLF)

  6, 36 and 60 months

• Target Vessel Revascularization (TVR)

  6, 12, 36 and 60 months

• Target Lesion Revascularization (TLR)

  6, 12, 36 and 60 months

• Stent Thrombosis

  6, 12, 36 and 60 months

• Clinical Device Success

  At time of intervention

Study Arms (1)

Orsiro DES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (43)

University Hospital Innsbruck

Innsbruck, 6020, Austria

Location

Clinica Tabancura

Santiago, Vitacura, Chile

Location

Gentofte Universitets Hospital

Hellerup, 2900, Denmark

Location

Clinique Rhone Durance

Avignon, 84082, France

Location

CHU Bocage Dijon

Dijon, 21034, France

Location

CCML Le Plessis Robinson

Le Plessis-Robinson, 92350, France

Location

CHRU Brabois Nancy

Nancy, 54500, France

Location

CH Niort

Niort, 79000, France

Location

Clinique Saint Hilaire Rouen

Rouen, 76000, France

Location

CHRU Rangueil Toulouse

Toulouse, 31403, France

Location

CHG Troyes

Troyes, 10003, France

Location

CH Valence

Valence, 26953, France

Location

Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Kardiologisch-Angiologische Praxis Hegeler

Bremen, 28277, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I

Halle, 06120, Germany

Location

Asklepiosklinik St. Georg

Hamburg, 20099, Germany

Location

Uniklinik Heidelberg, Medizinische Uniklinik

Heidelberg, 69120, Germany

Location

Klinikum Landshut-Achdorf Medizinische Klinik I

Landshut, 84036, Germany

Location

University of Leipzig

Leipzig, 04103, Germany

Location

LMU-Großhadern

Munich, 81377, Germany

Location

HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin

Munich, 81925, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Uniklink Regensburg

Regensburg, 93053, Germany

Location

Kliniken Villingen - Kardiologie

Villingen-Schwenningen, 78050, Germany

Location

Centro cardiologico Monzino

Milan, Italy

Location

Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata

Rome, 00133, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Riga Eastern Clinical University Hospital

Riga, 1038, Latvia

Location

VU Medical Center HV Amsterdam

Amsterdam, 1081 HV, Netherlands

Location

Alysis Hospital

Arnhem, 6815 AD, Netherlands

Location

Amphia Ziekenhuis Breda

Breda, 4818 CK, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

ZorgSaam Terneuzen

Terneuzen, 4535 PA, Netherlands

Location

Twee Steden Hospital Tilburg

Tilburg, 5042 AD, Netherlands

Location

Centro Hospitalar de Coimbra

São Martinho do Bispo, 3041-801, Portugal

Location

Hospital de Navarra

Pamplona, 31008, Spain

Location

Universitetssjukhuset Oerebro, Kardiologiska Kliniken

Örebro, 701 85, Sweden

Location

Clinique Cecil

Lausanne, 1003, Switzerland

Location

Kantonsspital Liestal

Liestal, 4410, Switzerland

Location

Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland

Belfast, BT63 5QQ, United Kingdom

Location

The Heart Hospital, UCLH

London, W1G 8PH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32890442 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.

  PMID: 30922870 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.

  PMID: 25782184 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Ischemia; Angina Pectoris; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Esther Gerteis

  Biotronik AG

  STUDY DIRECTOR

• Johannes Waltenberger, Prof.

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 14, 2012
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2017
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

FR (9); IT (2); SE (1); CH (2); AU (1); DE (14); CL (1); LA (2); NL (6); PT (1); GB (2); ES (1); DK (1)