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

NCT01939249 | Unknown

• 1 other identifier: C1204
• Study Type: interventional
• Target: 585
• Locations: 12 countries
• Sites: 45

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure

  12 months post index procedure

Secondary Outcomes (3)

• 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

Study Arms (2)

Abbott Laboratories Xience

ACTIVE COMPARATOR

Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).

Device: Abbott Laboratories Xience

Biotronik Orsiro

EXPERIMENTAL

Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro

Device: Biotronik Orsiro

Interventions

Abbott Laboratories Xience DEVICE

Abbott Laboratories Xience

Biotronik Orsiro DEVICE

Biotronik Orsiro

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (45)

Fiona Stanley Hospital

Murdoch, 6961, Australia

Location

Prince of Wales Hospital Sydney

Sydney, NSW 2031, Australia

Location

Gasthuisberg Leuven

Leuven, 3000, Belgium

Location

AZ Delta, H. Hart Roeselare

Roeselare, 8800, Belgium

Location

Roskilde Sygehus Nord

Roskilde, 4000, Denmark

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herz- und Diabeteszentrum NRW - Kardiologische Klinik

Bad Oeynhausen, 32545, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Charite Campus Mitte - Med. klinik für Kardiologie

Berlin, 10117, Germany

Location

Universitätsklinik Bonn

Bonn, 53105, Germany

Location

Amper Kliniken AG

Dachau, 85221, Germany

Location

Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie

Hanover, 30625, Germany

Location

Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued

Nuremberg, 90471, Germany

Location

Rambam Health Corporation, Rambam Medical Center, Batgalim

Haifa, 31096, Israel

Location

Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah

Jerusalem, 91120, Israel

Location

Clalit Health Services, Rabin Medical Center, Cardiology

Petah Tikva, 49100, Israel

Location

Tenjinkai Shinkoga Hospital

Fukuoka, Japan

Location

Akanekai Tsuchiya General Hospital

Hiroshima, Japan

Location

Hospital Hakodate

Hokkaido, Japan

Location

Sakurakai Takahashi Hospital

Hyōgo, Japan

Location

Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital

Kanagawa, Japan

Location

Okinawa Tokushukai Shonan Kamakura General Hospital

Kanagawa, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Kanagawa, Japan

Location

Japan Organization of Occupational Health and Safety Kansai Rosai Hospital

Kumamoto, Japan

Location

Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital

Kumamoto, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Japan

Location

Tokai University Hachioji Hospital

Tokyo, Japan

Location

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, 1091 AC, Netherlands

Location

Tergooi Blaricum

Blaricum, 1262 AN, Netherlands

Location

Amphia Hospital

Breda, 4818 CK, Netherlands

Location

Isala Klinieken

Zwolle, 8025 AB, Netherlands

Location

Cardiology Department, Christchurch Hospital

Christchurch, 4710, New Zealand

Location

University Hospital Krakow

Krakow, 31-501, Poland

Location

Miedziowe Centrum Zdrowia SA

Lubin, 59-300, Poland

Location

Clinical Hospital Medical University Poznan

Poznan, 61-848, Poland

Location

General Cardiology & Haemodynamics Dept., Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Virgen de la Macarena

Seville, 41071, Spain

Location

Universitetssjukhuset Örebro

Oerebrö, 70185, Sweden

Location

Akademiska Sjukhuset

Uppsala, 75185, Sweden

Location

University Hospital Lausanne

Lausanne, 1011, Switzerland

Location

CardioCentro Ticino

Lugano, 6900, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 39761745 DERIVED

• 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.

  PMID: 37062047 DERIVED

• 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.

  PMID: 35212802 DERIVED

• 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.

  PMID: 34056911 DERIVED

• 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.

  PMID: 32895004 DERIVED

• 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

• 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.

  PMID: 31235458 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shigeru Saito, MD

  Okinawa Tokushukai Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

• Ton Slagboom, MD

  Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: September 1, 2013
• Primary Completion: March 23, 2016
• Study Completion: January 1, 2020
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

DK (1); CH (3); BE (2); JP (11); SE (2); IL (3); NZ (1); DE (8); AU (2); NL (4); PL (4); ES (4)