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

June 23, 2017 updated by: Biotronik AG

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

585

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Murdoch, Australia, 6961
        • Fiona Stanley Hospital
      • Sydney, Australia, NSW 2031
        • Prince of Wales Hospital Sydney
  • Belgium
      • Leuven,, Belgium, 3000
        • Gasthuisberg Leuven
      • Roeselare, Belgium, 8800
        • AZ Delta, H. Hart Roeselare
  • Denmark
      • Roskilde, Denmark, 4000
        • Roskilde Sygehus Nord
  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Kardiologische Klinik
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken GmbH
      • Berlin, Germany, 10117
        • Charite Campus Mitte - Med. klinik für Kardiologie
      • Bonn, Germany, 53105
        • Universitätsklinik Bonn
      • Dachau, Germany, 85221
        • Amper Kliniken AG
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie
      • Nürnberg, Germany, 90471
        • Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Corporation, Rambam Medical Center, Batgalim
      • Jerusalem,, Israel, 91120
        • Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah
      • Petach Tikva, Israel, 49100
        • Clalit Health Services, Rabin Medical Center, Cardiology
  • Japan
      • Fukuoka, Japan
        • Tenjinkai Shinkoga Hospital
      • Hiroshima, Japan
        • Akanekai Tsuchiya General Hospital
      • Hokkaido, Japan
        • Hospital Hakodate
      • Hyogo, Japan
        • Sakurakai Takahashi Hospital
      • Kanagawa, 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
      • Kumamoto, Japan
        • Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
      • Kumamoto, Japan
        • Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital
      • Tokyo, Japan
        • Toho University Ohashi Medical Center
      • Tokyo, Japan
        • Tokai University Hachioji Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • Onze Lieve Vrouwe Gasthuis (OLVG)
      • Blaricum, Netherlands, 1262 AN
        • Tergooi Blaricum
      • Breda, Netherlands, 4818 CK
        • Amphia Hospital
      • Zwolle, Netherlands, 8025 AB
        • Isala Klinieken
  • New Zealand
      • Christchurch, New Zealand, 4710
        • Cardiology Department, Christchurch Hospital
  • Poland
      • Krakow, Poland, 31-501
        • University Hospital Krakow
      • Lubin, Poland, 59-300
        • Miedziowe Centrum Zdrowia SA
      • Poznan, Poland, 61-848
        • Clinical Hospital Medical University Poznan
      • Warsaw, Poland, 04-628
        • General Cardiology & Haemodynamics Dept., Institute of Cardiology
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínico y Provincial de Barcelona
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain, 41071
        • Hospital Virgen de la Macarena
  • Sweden
      • Oerebrö, Sweden, 70185
        • Universitetssjukhuset Örebro
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Switzerland
      • Lausanne, Switzerland, 1011
        • University Hospital Lausanne
      • Lugano, Switzerland, 6900
        • Cardiocentro Ticino
      • Zürich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abbott Laboratories Xience
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
Experimental: Biotronik Orsiro
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Device: Biotronik Orsiro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target Vessel Failure
Time Frame: 12 months post index procedure
12 months post index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Investigators

  • Principal Investigator: Shigeru Saito, MD, Okinawa Tokushukai Shonan Kamakura General Hospital
  • Principal Investigator: Ton Slagboom, MD, Onze Lieve Vrouwe Gasthuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 23, 2016

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1204 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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