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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01939249




Registration number
NCT01939249
Ethics application status
Date submitted
6/09/2013
Date registered
11/09/2013
Date last updated
26/06/2017

Titles & IDs
Public title
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
Scientific 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
Secondary ID [1] 0 0
C1204
Universal Trial Number (UTN)
Trial acronym
BIOFLOW-IV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).

Experimental: Biotronik Orsiro - Subjects assigned to Biotronik Orsiro will be treated with Biotronik Orsiro
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Vessel Failure
Timepoint [1] 0 0
12 months post index procedure
Secondary outcome [1] 0 0
Rate of clinically-driven target lesion revascularization (TLR)
Timepoint [1] 0 0
1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Secondary outcome [2] 0 0
Rate of clinically-driven target vessel revascularization (TVR)
Timepoint [2] 0 0
1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
585
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 0 0
Prince of Wales Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
6961 - Murdoch
Recruitment postcode(s) [2] 0 0
NSW 2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven,
Country [2] 0 0
Belgium
State/province [2] 0 0
Roeselare
Country [3] 0 0
Denmark
State/province [3] 0 0
Roskilde
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Krozingen
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Oeynhausen
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Segeberg
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
Germany
State/province [9] 0 0
Dachau
Country [10] 0 0
Germany
State/province [10] 0 0
Hannover
Country [11] 0 0
Germany
State/province [11] 0 0
Nürnberg
Country [12] 0 0
Israel
State/province [12] 0 0
Haifa
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem,
Country [14] 0 0
Israel
State/province [14] 0 0
Petach Tikva
Country [15] 0 0
Japan
State/province [15] 0 0
Fukuoka
Country [16] 0 0
Japan
State/province [16] 0 0
Hiroshima
Country [17] 0 0
Japan
State/province [17] 0 0
Hokkaido
Country [18] 0 0
Japan
State/province [18] 0 0
Hyogo
Country [19] 0 0
Japan
State/province [19] 0 0
Kanagawa
Country [20] 0 0
Japan
State/province [20] 0 0
Kumamoto
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Blaricum
Country [24] 0 0
Netherlands
State/province [24] 0 0
Breda
Country [25] 0 0
Netherlands
State/province [25] 0 0
Zwolle
Country [26] 0 0
New Zealand
State/province [26] 0 0
Christchurch
Country [27] 0 0
Poland
State/province [27] 0 0
Krakow
Country [28] 0 0
Poland
State/province [28] 0 0
Lubin
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Santander
Country [33] 0 0
Spain
State/province [33] 0 0
Sevilla
Country [34] 0 0
Sweden
State/province [34] 0 0
Oerebrö
Country [35] 0 0
Sweden
State/province [35] 0 0
Uppsala
Country [36] 0 0
Switzerland
State/province [36] 0 0
Lausanne
Country [37] 0 0
Switzerland
State/province [37] 0 0
Lugano
Country [38] 0 0
Switzerland
State/province [38] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik AG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01939249
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Shigeru Saito, MD
Address 0 0
Okinawa Tokushukai Shonan Kamakura General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01939249