Clinical trial NCT01939249: Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
Official title: BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.


Eligibility criteria: Main Inclusion Criteria:

* Subject must provide written informed consent
* The target reference vessel diameter (RVD) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online QCA.
* Target lesion length is ≤ 26 mm (assessed either visual estimate or by online QCA) and can be covered by one study stent
* Single de novo lesion with ≥ 50% and \< 100% stenosis in up to 2 coronary arteries

Main Exclusion Criteria:

* Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
* Planned intervention of non-target vessel(s) within 30 days after the index procedure
* Planned intervention of target vessel(s) after the index procedure
* Target lesion is located in the left main
* Target lesion is located in or supplied by an arterial or venous bypass graft
* Target lesion involves a side branch \> 2.0 mm in diameter by visual estimate or by online QCA
* Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off

Primary outcomes:
measure: Target Vessel Failure
timeFrame: 12 months post index procedure
Secondary outcomes:
measure: Rate of clinically-driven target lesion revascularization (TLR)
timeFrame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
measure: Rate of clinically-driven target vessel revascularization (TVR)
timeFrame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
measure: Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR
timeFrame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Other outcomes:
Locations:
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Sydney
country: Australia
facility: Prince of Wales Hospital Sydney
city: Leuven,
country: Belgium
facility: Gasthuisberg Leuven
city: Roeselare
country: Belgium
facility: AZ Delta, H. Hart Roeselare
city: Roskilde
country: Denmark
facility: Roskilde Sygehus Nord
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Kardiologische Klinik
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charite Campus Mitte - Med. klinik für Kardiologie
city: Bonn
country: Germany
facility: Universitätsklinik Bonn
city: Dachau
country: Germany
facility: Amper Kliniken AG
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie
city: Nürnberg
country: Germany
facility: Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued
city: Haifa
country: Israel
facility: Rambam Health Corporation, Rambam Medical Center, Batgalim
city: Jerusalem,
country: Israel
facility: Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah
city: Petach Tikva
country: Israel
facility: Clalit Health Services, Rabin Medical Center, Cardiology
city: Fukuoka
country: Japan
facility: Tenjinkai Shinkoga Hospital
city: Hiroshima
country: Japan
facility: Akanekai Tsuchiya General Hospital
city: Hokkaido
country: Japan
facility: Hospital Hakodate
city: Hyogo
country: Japan
facility: Sakurakai Takahashi Hospital
city: Kanagawa
country: Japan
facility: Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital
city: Kanagawa
country: Japan
facility: Okinawa Tokushukai Shonan Kamakura General Hospital
city: Kanagawa
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
city: Kumamoto
country: Japan
facility: Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
city: Kumamoto
country: Japan
facility: Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Tokai University Hachioji Hospital
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
city: Blaricum
country: Netherlands
facility: Tergooi Blaricum
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Christchurch
country: New Zealand
facility: Cardiology Department, Christchurch Hospital
city: Krakow
country: Poland
facility: University Hospital Krakow
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia SA
city: Poznan
country: Poland
facility: Clinical Hospital Medical University Poznan
city: Warsaw
country: Poland
facility: General Cardiology & Haemodynamics Dept., Institute of Cardiology
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Oerebrö
country: Sweden
facility: Universitetssjukhuset Örebro
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: Lugano
country: Switzerland
facility: CardioCentro Ticino
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Okinawa Tokushukai Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onze Lieve Vrouwe Gasthuis
name: Ton Slagboom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hemetsberger R, Abdelghani M, Toelg R, Garcia-Garcia HM, Farhan S, Mankerious N, Elbasha K, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Complex vs. non-complex percutaneous coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2022 Jul;111(7):795-805. doi: 10.1007/s00392-022-01994-4. Epub 2022 Feb 25.
citation: Hemetsberger R, Abdelghani M, Toelg R, Mankerious N, Allali A, Garcia-Garcia HM, Windecker S, Lefevre T, Saito S, Slagboom T, Kandzari D, Koolen J, Waksman R, Richardt G. Impact of Coronary Calcification on Clinical Outcomes After Implantation of Newer-Generation Drug-Eluting Stents. J Am Heart Assoc. 2021 Jun 15;10(12):e019815. doi: 10.1161/JAHA.120.019815. Epub 2021 May 29.
citation: Dan K, Garcia-Garcia HM, Kolm P, Windecker S, Saito S, Kandzari DE, Waksman R. Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circ Cardiovasc Interv. 2020 Sep;13(9):e009189. doi: 10.1161/CIRCINTERVENTIONS.120.009189. Epub 2020 Sep 8.
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: Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention. 2019 Dec 6;15(11):e1006-e1013. doi: 10.4244/EIJ-D-18-01214.