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Coronary Artery DiseaseBIOFLOW-IVNCT01939249

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

A study testing Abbott Laboratories Xience and Biotronik Orsiro in people with Coronary Artery Disease, run by Biotronik AG at 45 sites in 12 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Abbott Laboratories Xience and Biotronik Orsiro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
585 participants
Where
45 sitesin 12 countries
Study dates
Sep 2013to Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

45 sites in 12 countries.

45 sites in 12 countries

Japan11 sites

  • Tenjinkai Shinkoga Hospital

    Fukuoka

  • Akanekai Tsuchiya General Hospital

    Hiroshima

  • Hospital Hakodate

    Hokkaido

  • Sakurakai Takahashi Hospital

    Hyōgo

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

    Kanagawa

  • Okinawa Tokushukai Shonan Kamakura General Hospital

    Kanagawa

  • Saiseikai Yokohamashi Tobu Hospital

    Kanagawa

  • Japan Organization of Occupational Health and Safety Kansai Rosai Hospital

    Kumamoto

  • Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital

    Kumamoto

  • Toho University Ohashi Medical Center

    Tokyo

  • Tokai University Hachioji Hospital

    Tokyo

Other trials in Japan

Germany8 sites

  • Universitäts-Herzzentrum Freiburg Bad Krozingen

    Bad Krozingen, 79189

  • Herz- und Diabeteszentrum NRW - Kardiologische Klinik

    Bad Oeynhausen, 32545

  • Segeberger Kliniken GmbH

    Bad Segeberg, 23795

  • Charite Campus Mitte - Med. klinik für Kardiologie

    Berlin, 10117

  • Universitätsklinik Bonn

    Bonn, 53105

  • Amper Kliniken AG

    Dachau, 85221

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

    Hanover, 30625

  • Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued

    Nuremberg, 90471

Other trials in Germany

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam, 1091 AC

  • Tergooi Blaricum

    Blaricum, 1262 AN

  • Amphia Hospital

    Breda, 4818 CK

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

Poland4 sites

  • University Hospital Krakow

    Krakow, 31-501

  • Miedziowe Centrum Zdrowia SA

    Lubin, 59-300

  • Clinical Hospital Medical University Poznan

    Poznan, 61-848

  • General Cardiology & Haemodynamics Dept., Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

Spain4 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clínico y Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Virgen de la Macarena

    Seville, 41071

Other trials in Spain

Israel3 sites

  • Rambam Health Corporation, Rambam Medical Center, Batgalim

    Haifa, 31096

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

    Jerusalem, 91120

  • Clalit Health Services, Rabin Medical Center, Cardiology

    Petah Tikva, 49100

Other trials in Israel

Switzerland3 sites

  • University Hospital Lausanne

    Lausanne, 1011

  • CardioCentro Ticino

    Lugano, 6900

  • University Hospital Zürich

    Zurich, 8091

Other trials in Switzerland

Australia2 sites

  • Fiona Stanley Hospital

    Murdoch, 6961

  • Prince of Wales Hospital Sydney

    Sydney, NSW 2031

Other trials in Australia

Belgium2 sites

  • Gasthuisberg Leuven

    Leuven, 3000

  • AZ Delta, H. Hart Roeselare

    Roeselare, 8800

Other trials in Belgium

Sweden2 sites

  • Universitetssjukhuset Örebro

    Oerebrö, 70185

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Denmark1 site

  • Roskilde Sygehus Nord

    Roskilde, 4000

Other trials in Denmark

New Zealand1 site

  • Cardiology Department, Christchurch Hospital

    Christchurch, 4710

Other trials in New Zealand

About this study

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

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.

Being tested
Abbott Laboratories Xience, Biotronik Orsiro
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abbott Laboratories XienceDevice

  • Biotronik OrsiroDevice

Study groups in NCT01939249
Study groupRoleWhat they receive
Abbott Laboratories XienceActive comparatorSubjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Receives: Device: Abbott Laboratories Xience
Biotronik OrsiroExperimentalSubjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Receives: Device: Biotronik Orsiro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Failure

    Measured: 12 months post index procedure

Secondary outcomes (3)

  1. Rate of clinically-driven target lesion revascularization (TLR)

    Measured: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year

  2. Rate of clinically-driven target vessel revascularization (TVR)

    Measured: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year

  3. 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

    Measured: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completion23 Mar 2016
  4. Study completionJan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
585 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939249
Sponsor's protocol ID
C1204
Acronym
BIOFLOW-IV
Status last verified
Jun 2017
First submitted
6 Sep 2013
Last updated
26 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39761745

  • 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.

    PubMed 37062047

  • 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.

    PubMed 35212802

  • 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.

    PubMed 34056911

  • 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.

    PubMed 32895004

  • 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.

    PubMed 32890442

  • 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.

    PubMed 31235458

Questions about this trial

What is this clinical trial studying?

A study testing Abbott Laboratories Xience and Biotronik Orsiro in people with Coronary Artery Disease, run by Biotronik AG at 45 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Japan, Germany, Netherlands, Poland, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (time frame: 12 months post index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939249, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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