Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Abbott Laboratories Xience; Device: Biotronik Orsiro

• Registration Number: NCT01939249
• Lead Sponsor: Biotronik AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-11
• Primary Completion: 2016-03-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 585

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abbott Laboratories Xience	Abbott Laboratories Xience	Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Biotronik Orsiro	Biotronik Orsiro	Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	12 months post index procedure

Secondary Outcome Measures

Name	Time	Method
Rate of clinically-driven target lesion revascularization (TLR)	1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Rate of clinically-driven target vessel revascularization (TVR)	1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
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	1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year

Trial Locations

Locations (45)

Prince of Wales Hospital Sydney; 🇦🇺 Sydney, Australia

Gasthuisberg Leuven; 🇧🇪 Leuven,, Belgium

Akanekai Tsuchiya General Hospital; 🇯🇵 Hiroshima, Japan

Clalit Health Services, Rabin Medical Center, Cardiology; 🇮🇱 Petach Tikva, Israel

Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital; 🇯🇵 Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital; 🇯🇵 Kanagawa, Japan

University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland

CardioCentro Ticino; 🇨🇭 Lugano, Switzerland

Toho University Ohashi Medical Center; 🇯🇵 Tokyo, Japan

University Hospital Krakow; 🇵🇱 Krakow, Poland

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

Cardiology Department, Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

AZ Delta, H. Hart Roeselare; 🇧🇪 Roeselare, Belgium

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Universitäts-Herzzentrum Freiburg Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Herz- und Diabeteszentrum NRW - Kardiologische Klinik; 🇩🇪 Bad Oeynhausen, Germany

Roskilde Sygehus Nord; 🇩🇰 Roskilde, Denmark

Universitätsklinik Bonn; 🇩🇪 Bonn, Germany

Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie; 🇩🇪 Hannover, Germany

Amper Kliniken AG; 🇩🇪 Dachau, Germany

Charite Campus Mitte - Med. klinik für Kardiologie; 🇩🇪 Berlin, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued; 🇩🇪 Nürnberg, 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

Tenjinkai Shinkoga Hospital; 🇯🇵 Fukuoka, Japan

Hospital Hakodate; 🇯🇵 Hokkaido, Japan

Sakurakai Takahashi Hospital; 🇯🇵 Hyogo, Japan

Okinawa Tokushukai Shonan Kamakura General 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

Amphia Hospital; 🇳🇱 Breda, Netherlands

Tergooi Blaricum; 🇳🇱 Blaricum, Netherlands

Onze Lieve Vrouwe Gasthuis (OLVG); 🇳🇱 Amsterdam, Netherlands

Tokai University Hachioji Hospital; 🇯🇵 Tokyo, Japan

Clinical Hospital Medical University Poznan; 🇵🇱 Poznan, Poland

Miedziowe Centrum Zdrowia SA; 🇵🇱 Lubin, Poland

Hospital del Mar; 🇪🇸 Barcelona, Spain

General Cardiology & Haemodynamics Dept., Institute of Cardiology; 🇵🇱 Warsaw, Poland

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Akademiska Sjukhuset; 🇸🇪 Uppsala, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Oerebrö, Sweden