Back to resultsProspective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent (BIOFLOW-IV)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abbott Laboratories Xience
Biotronik Orsiro
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Fiona Stanley Hospital
- Prince of Wales Hospital Sydney
- Gasthuisberg Leuven
- AZ Delta, H. Hart Roeselare
- Roskilde Sygehus Nord
- Universitäts-Herzzentrum Freiburg Bad Krozingen
- Herz- und Diabeteszentrum NRW - Kardiologische Klinik
- Segeberger Kliniken GmbH
- Charite Campus Mitte - Med. klinik für Kardiologie
- Universitätsklinik Bonn
- Amper Kliniken AG
- Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie
- Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued
- Rambam Health Corporation, Rambam Medical Center, Batgalim
- Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah
- Clalit Health Services, Rabin Medical Center, Cardiology
- Tenjinkai Shinkoga Hospital
- Akanekai Tsuchiya General Hospital
- Hospital Hakodate
- Sakurakai Takahashi Hospital
- Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital
- Okinawa Tokushukai Shonan Kamakura General Hospital
- Saiseikai Yokohamashi Tobu Hospital
- Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
- Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital
- Toho University Ohashi Medical Center
- Tokai University Hachioji Hospital
- Onze Lieve Vrouwe Gasthuis (OLVG)
- Tergooi Blaricum
- Amphia Hospital
- Isala Klinieken
- Cardiology Department, Christchurch Hospital
- University Hospital Krakow
- Miedziowe Centrum Zdrowia SA
- Clinical Hospital Medical University Poznan
- General Cardiology & Haemodynamics Dept., Institute of Cardiology
- Hospital del Mar
- Hospital Clínico y Provincial de Barcelona
- Hospital Universitario Marqués de Valdecilla
- Hospital Virgen de la Macarena
- Universitetssjukhuset Örebro
- Akademiska Sjukhuset
- University Hospital Lausanne
- CardioCentro Ticino
- University Hospital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Abbott Laboratories Xience
Biotronik Orsiro
Arm Description
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Outcomes
Primary Outcome Measures
Target Vessel Failure
Secondary Outcome Measures
Rate of clinically-driven target lesion revascularization (TLR)
Rate of clinically-driven target vessel revascularization (TVR)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01939249
Brief Title
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
Acronym
BIOFLOW-IV
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
585 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abbott Laboratories Xience
Arm Type
Active Comparator
Arm Description
Subjects assigned to Abbott Laboratories Xience can be treated with either the Xience Prime or Xience Xpedition drug eluting stent (DES).
Arm Title
Biotronik Orsiro
Arm Type
Experimental
Arm Description
Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Intervention Type
Device
Intervention Name(s)
Abbott Laboratories Xience
Intervention Type
Device
Intervention Name(s)
Biotronik Orsiro
Primary Outcome Measure Information:
Title
Target Vessel Failure
Time Frame
12 months post index procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Okinawa Tokushukai Shonan Kamakura General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ton Slagboom, MD
Organizational Affiliation
Onze Lieve Vrouwe Gasthuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6961
Country
Australia
Facility Name
Prince of Wales Hospital Sydney
City
Sydney
ZIP/Postal Code
NSW 2031
Country
Australia
Facility Name
Gasthuisberg Leuven
City
Leuven,
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta, H. Hart Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Roskilde Sygehus Nord
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Universitäts-Herzzentrum Freiburg Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW - Kardiologische Klinik
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charite Campus Mitte - Med. klinik für Kardiologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Amper Kliniken AG
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH), Klinik für Kardiologie und Angiologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Medizinische Klinik 8-Kardiologie -Klinikum Nürnberg Sued
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Rambam Health Corporation, Rambam Medical Center, Batgalim
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hedasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Medical Center Kiryat Hadassah
City
Jerusalem,
ZIP/Postal Code
91120
Country
Israel
Facility Name
Clalit Health Services, Rabin Medical Center, Cardiology
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tenjinkai Shinkoga Hospital
City
Fukuoka
Country
Japan
Facility Name
Akanekai Tsuchiya General Hospital
City
Hiroshima
Country
Japan
Facility Name
Hospital Hakodate
City
Hokkaido
Country
Japan
Facility Name
Sakurakai Takahashi Hospital
City
Hyogo
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Kanto Rosai Hos-pital
City
Kanagawa
Country
Japan
Facility Name
Okinawa Tokushukai Shonan Kamakura General Hospital
City
Kanagawa
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Kanagawa
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
City
Kumamoto
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Kumamoto Rosai Hospital
City
Kumamoto
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Tokyo
Country
Japan
Facility Name
Onze Lieve Vrouwe Gasthuis (OLVG)
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Tergooi Blaricum
City
Blaricum
ZIP/Postal Code
1262 AN
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Cardiology Department, Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
University Hospital Krakow
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Miedziowe Centrum Zdrowia SA
City
Lubin
ZIP/Postal Code
59-300
Country
Poland
Facility Name
Clinical Hospital Medical University Poznan
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
General Cardiology & Haemodynamics Dept., Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Universitetssjukhuset Örebro
City
Oerebrö
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
University Hospital Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
CardioCentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35212802
Citation
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.
Results Reference
derived
PubMed Identifier
34056911
Citation
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.
Results Reference
derived
PubMed Identifier
32895004
Citation
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.
Results Reference
derived
PubMed Identifier
32890442
Citation
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.
Results Reference
derived
PubMed Identifier
31235458
Citation
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.
Results Reference
derived
Learn more about this trial
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
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