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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01939249
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Abbott Laboratories Xience Device: Biotronik Orsiro Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2013
Actual Primary Completion Date : March 23, 2016
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

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



Primary Outcome Measures :
  1. Target Vessel Failure [ Time Frame: 12 months post index procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  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 [ Time Frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939249


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

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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01939249     History of Changes
Other Study ID Numbers: C1204
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs