Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
NCT ID: NCT01939249
Last Updated: 2017-06-26
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
NA
585 participants
INTERVENTIONAL
2013-09-30
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abbott Laboratories Xience
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Abbott Laboratories Xience
Biotronik Orsiro
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Biotronik Orsiro
Interventions
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Abbott Laboratories Xience
Biotronik Orsiro
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Principal Investigators
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Shigeru Saito, MD
Role: PRINCIPAL_INVESTIGATOR
Okinawa Tokushukai Shonan Kamakura General Hospital
Ton Slagboom, MD
Role: PRINCIPAL_INVESTIGATOR
Onze Lieve Vrouwe Gasthuis
Locations
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Fiona Stanley Hospital
Murdoch, , Australia
Prince of Wales Hospital Sydney
Sydney, , Australia
Gasthuisberg Leuven
Leuven, , Belgium
AZ Delta, H. Hart Roeselare
Roeselare, , Belgium
Roskilde Sygehus Nord
Roskilde, , Denmark
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, , Germany
Herz- und Diabeteszentrum NRW - Kardiologische Klinik
Bad Oeynhausen, , Germany
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Charite Campus Mitte - Med. klinik für Kardiologie
Berlin, , Germany
Universitätsklinik Bonn
Bonn, , Germany
Amper Kliniken AG
Dachau, , Germany
Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie
Hanover, , Germany
Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued
Nuremberg, , Germany
Rambam Health Corporation, Rambam Medical Center, Batgalim
Haifa, , Israel
Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah
Jerusalem, , Israel
Clalit Health Services, Rabin Medical Center, Cardiology
Petah Tikva, , Israel
Tenjinkai Shinkoga Hospital
Fukuoka, , Japan
Akanekai Tsuchiya General Hospital
Hiroshima, , Japan
Hospital Hakodate
Hokkaido, , Japan
Sakurakai Takahashi Hospital
Hyōgo, , Japan
Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital
Kanagawa, , Japan
Okinawa Tokushukai Shonan Kamakura General Hospital
Kanagawa, , Japan
Saiseikai Yokohamashi Tobu Hospital
Kanagawa, , Japan
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
Kumamoto, , Japan
Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital
Kumamoto, , Japan
Toho University Ohashi Medical Center
Tokyo, , Japan
Tokai University Hachioji Hospital
Tokyo, , Japan
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, , Netherlands
Tergooi Blaricum
Blaricum, , Netherlands
Amphia Hospital
Breda, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Cardiology Department, Christchurch Hospital
Christchurch, , New Zealand
University Hospital Krakow
Krakow, , Poland
Miedziowe Centrum Zdrowia SA
Lubin, , Poland
Clinical Hospital Medical University Poznan
Poznan, , Poland
General Cardiology & Haemodynamics Dept., Institute of Cardiology
Warsaw, , Poland
Hospital del Mar
Barcelona, , Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Virgen de la Macarena
Seville, , Spain
Universitetssjukhuset Örebro
Oerebrö, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
University Hospital Lausanne
Lausanne, , Switzerland
CardioCentro Ticino
Lugano, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
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References
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Mankerious N, Toelg R, Abdelghani M, Garcia-Garcia HM, Farhan S, Allali A, Windecker S, Lefevre T, Saito S, Kandzari DE, Waksman R, Richardt G, Hemetsberger R. Impact of coronary artery tortuosity on outcomes following stenting with newer-generation drug-eluting stents. An analysis of the randomized BIOFLOW trials. Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):682-691. doi: 10.1016/j.rec.2024.12.009. Epub 2025 Jan 4. English, Spanish.
Hemetsberger R, Mankerious N, Toelg R, Abdelghani M, Farhan S, Garcia-Garica HM, Allali A, Windecker S, Lefevre T, Saito S, Kandzari D, Waksman R, Richardt G. Patients with higher-atherothrombotic risk vs. lower-atherothrombotic risk undergoing coronary intervention with newer-generation drug-eluting stents: an analysis from the randomized BIOFLOW trials. Clin Res Cardiol. 2023 Sep;112(9):1278-1287. doi: 10.1007/s00392-023-02205-4. Epub 2023 Apr 16.
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.
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.
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.
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.
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.
Other Identifiers
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C1204
Identifier Type: -
Identifier Source: org_study_id
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