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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Marques 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Target Vessel Failure
Time Frame: 12 months post index procedure
12 months post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings