Clinical trial NCT01553526: BIOFLOW-III All-comers Orsiro Safety and Performance Registry
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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)
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 1356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 6, 36 and 60 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 6, 12, 36 and 60 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6, 12, 36 and 60 months
measure: Stent Thrombosis
timeFrame: 6, 12, 36 and 60 months
measure: Clinical Device Success
timeFrame: At time of intervention
measure: Clinical Procedural Success
timeFrame: During the hospital stay to a maximum of the first seven days post index procedure
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
city: Santiago
country: Chile
facility: Clinica Tabancura
city: Hellerup
country: Denmark
facility: Gentofte Universitets Hospital
city: Avignon
country: France
facility: Clinique Rhone Durance
city: Dijon
country: France
facility: CHU Bocage Dijon
city: Le Plessis Robinson
country: France
facility: CCML Le Plessis Robinson
city: Nancy
country: France
facility: CHRU Brabois Nancy
city: Niort
country: France
facility: CH Niort
city: Rouen
country: France
facility: Clinique Saint Hilaire Rouen
city: Toulouse
country: France
facility: CHRU Rangueil Toulouse
city: Troyes
country: France
facility: CHG Troyes
city: Valence
country: France
facility: CH Valence
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Klinikum im Friedrichshain
city: Bremen
country: Germany
facility: Kardiologisch-Angiologische Praxis Hegeler
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Halle
country: Germany
facility: Krankenhaus Martha Maria gGmbH, Klinik fuer Innere Medizin I
city: Hamburg
country: Germany
facility: Asklepiosklinik St. Georg
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg, Medizinische Uniklinik
city: Landshut
country: Germany
facility: Klinikum Landshut-Achdorf Medizinische Klinik I
city: Leipzig
country: Germany
facility: University of Leipzig
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: LMU-Großhadern
city: Munich
country: Germany
facility: HZ Muenchen-Bogenhausen, Klinik fuer Kardiologie und Internistische Intensivmedizin
city: Regensburg
country: Germany
facility: Uniklink Regensburg
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen - Kardiologie
city: Milano
country: Italy
facility: Centro cardiologico Monzino
city: Rome
country: Italy
facility: Cattedra Universitaria, Divisione Cardiologia, Policlinico Tor Vergata
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga Eastern Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: VU Medical Center HV Amsterdam
city: Arnhem
country: Netherlands
facility: Alysis Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Terneuzen
country: Netherlands
facility: ZorgSaam Terneuzen
city: Tilburg
country: Netherlands
facility: Twee Steden Hospital Tilburg
city: Sao Martinho do Bispo
country: Portugal
facility: Centro Hospitalar de Coimbra
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Oerebro
country: Sweden
facility: Universitetssjukhuset Oerebro, Kardiologiska Kliniken
city: Lausanne
country: Switzerland
facility: Clinique Cecil
city: Liestal
country: Switzerland
facility: Kantonsspital Liestal
city: Belfast
country: United Kingdom
facility: Craigavon Area Hospital Lurgan Road Co. Armagh, Northern Ireland
city: London
country: United Kingdom
facility: The Heart Hospital, UCLH
Study officials:
affiliation: Biotronik AG
name: Esther Gerteis
role: STUDY_DIRECTOR
affiliation: University Hospital Muenster
name: Johannes Waltenberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.