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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02389946




Registration number
NCT02389946
Ethics application status
Date submitted
2/03/2015
Date registered
17/03/2015
Date last updated
1/08/2019

Titles & IDs
Public title
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Scientific title
BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - V
Secondary ID [1] 0 0
BIOFLOW-V
Universal Trial Number (UTN)
Trial acronym
BIOFLOW-V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Atherosclerosis, Coronary 0 0
Myocardial Ischemia 0 0
Ischemic Heart Disease 0 0
Acute Coronary Syndrome 0 0
Angina Pectoris 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Orsiro DES
Treatment: Devices - Xience DES

Experimental: Orsiro sirolimus coronary stent system - Intervention with a Orsiro DES.

Active Comparator: Xience everolimus coronary stent system - Intervention with a Xience DES.


Treatment: Devices: Orsiro DES
Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.

Treatment: Devices: Xience DES


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation - TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Timepoint [1] 0 0
12-Months
Secondary outcome [1] 0 0
Number of Lesions With Device Success - Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only.
Timepoint [1] 0 0
Hospital Discharge (6-24 hours post-index procedure)
Secondary outcome [2] 0 0
Number of Lesions With Lesion Success - Defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method.
Timepoint [2] 0 0
Hospital Discharge (6-24 hours post-index procedure)
Secondary outcome [3] 0 0
Number of Participants With Procedure Success - Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Timepoint [3] 0 0
Hospital Discharge (6-24 hours post-index procedure)
Secondary outcome [4] 0 0
Number of Participants With Myocardial Infarction
Timepoint [4] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Secondary outcome [5] 0 0
Number of Participants With Myocardial Infarction or Cardiac Death - Anticipated reporting: April 2022.
Timepoint [5] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Secondary outcome [6] 0 0
Number of Participants With MACE and Individual MACE Components - MACE: composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR
Timepoint [6] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Secondary outcome [7] 0 0
Number of Participants With TLF and Individual TLF Components - TLF: composite of cardiac death, target vessel Q-wave or non-Q-wave MI, and any clinically-driven TLR
Timepoint [7] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Secondary outcome [8] 0 0
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components - TVF: composite of cardiac death, target vessel Q-wave or non-Q-wave MI, and any clinically-driven TVR.
Timepoint [8] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years
Secondary outcome [9] 0 0
Number of Participants With Stent Thrombosis - Stent thrombosis according to the Academic Research Consortium criteria.
Timepoint [9] 0 0
Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years

Eligibility
Key inclusion criteria
1. Subject is =18 years or the minimum age required for legal adult consent in the
country of enrollment.

2. Subject is an acceptable candidate for PCI.

3. Subject is an acceptable candidate for CABG.

4. Subject has clinical evidence of ischemic heart disease, stable or unstable angina
pectoris or documented silent ischemia.

5. Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either,
clopidogrel, prasugrel, ticagrelor or ticlopidine.

6. Subject has provided written informed consent.

7. Subject is willing to comply with study follow-up requirements.

Each target lesion/vessel must meet all of the following angiographic criteria for the
subject to be eligible for the trial:

1. Subject has up to three target lesions in up to two separate target vessels (two
target lesions in one vessel and one target lesion in a separate vessel).

2. Target lesion must be de novo or restenotic lesion in native coronary artery;
restenotic lesion must have been treated with a standard PTCA only.

3. Target lesion must be in major coronary artery or branch (target vessel).

4. Target lesion must have angiographic evidence of = 50% and < 100% stenosis (by
operator visual estimate). If the target lesion is < 70% stenosed, clinical evidence
of ischemia by positive functional study, CT, electrocardiography, FFR, or post
infarct angina.

5. TIMI flow > 1.

6. Target lesion must be = 36 mm in length by operator visual estimate.

7. Target vessel RVD of 2.25-4.0 mm by operator visual estimate.

8. Target lesion must be treatable with a maximum of two overlapping stents.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index
procedure. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study
enrollment.

2. Subject is hemodynamically unstable.

3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the
duration of the study.

4. Subject has a known allergy to contrast medium that cannot be adequately
pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and
bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt,
chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA,
sirolimus or everolimus.

5. Revascularization of any target vessel within 9 months prior to the index procedure or
previous PCI of any non-target vessel within 30 days prior to the index procedure.

6. Planned treatment of a lesion not meeting angiographic inclusion and exclusion
criteria during the index procedure or after the index procedure.

7. Planned surgery within 6 months of index procedure unless dual antiplatelet therapy
can be maintained throughout the peri-surgical period.

8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the
index procedure.

9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who
are ineligible for DAPT.

10. Subject will refuse blood transfusions.

11. Subject has documented left ventricular ejection fraction (LVEF) < 30% within 90 days
prior to the index procedure.

12. Subject is dialysis-dependent.

13. Subject has impaired renal function (i.e., blood creatinine > 2.5 mg/dL or 221 µmol/L
determined within 7 days prior to the index procedure).

14. Subject has leukopenia (i.e. < 3,000 white blood cells/mm3), thrombocytopenia (i.e. <
100,000 platelets/mm3) or thrombocytosis (i.e. > 700,000 platelet/mm3).

15. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids
are permitted), or has known life-limiting immunosuppressive or autoimmune disease
(e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus
is permitted).

16. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban,
rivaroxaban or any other agent).

17. Subject has life expectancy of < 1 year.

18. Subject is participating in another investigational (medical device or drug) clinical
study. Subjects may be concurrently enrolled in a post-market study, as long as the
post-market study device, drug or protocol does not interfere with the investigational
treatment or protocol of this study.

19. In the investigator's opinion, subject will not be able to comply with the follow-up
requirements.

Subjects will be excluded from the trial if any of the target lesions/vessels meets any of
the following angiographic criteria:

1. Target lesion is located within a saphenous vein graft or arterial graft.

2. Target lesion is a restenotic lesion that was previously treated with a bare metal or
drug eluting stent (in-stent restenosis).

3. Target lesion has any of the following characteristics:

1. Lesion location is within the left main coronary artery, or within 3 mm of the
origin of the left anterior descending (LAD) or left circumflex (LCX).

2. Involves a side branch of > 2.0 mm in diameter. Note: Lesions within 3 mm of the
origin of the right coronary artery may be treated.

4. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that
would prevent complete inflation of an angioplasty balloon. This assessment should be
based on visual estimation.

5. Target vessel has angiographic evidence of thrombus.

6. Target lesion is totally occluded (100% stenosis).

7. Target vessel was treated with brachytherapy any time prior to the index procedure.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
SA 5011 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
Belgium
State/province [26] 0 0
Genk
Country [27] 0 0
Belgium
State/province [27] 0 0
Leuven
Country [28] 0 0
Belgium
State/province [28] 0 0
Roeselare
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Denmark
State/province [30] 0 0
Aarhus
Country [31] 0 0
Germany
State/province [31] 0 0
Bad Segeberg
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Minden
Country [35] 0 0
Germany
State/province [35] 0 0
Neuss
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Hungary
State/province [37] 0 0
Pécs
Country [38] 0 0
Hungary
State/province [38] 0 0
Szeged
Country [39] 0 0
Israel
State/province [39] 0 0
Haifa
Country [40] 0 0
Israel
State/province [40] 0 0
Jerusalem
Country [41] 0 0
Israel
State/province [41] 0 0
Petach Tikva
Country [42] 0 0
Israel
State/province [42] 0 0
Rehovot
Country [43] 0 0
Israel
State/province [43] 0 0
Tel Aviv
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Daegu
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Gwangju
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Netherlands
State/province [47] 0 0
Breda
Country [48] 0 0
Netherlands
State/province [48] 0 0
Eindhoven
Country [49] 0 0
Netherlands
State/province [49] 0 0
Nieuwegein
Country [50] 0 0
New Zealand
State/province [50] 0 0
Auckland
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Malaga
Country [54] 0 0
Spain
State/province [54] 0 0
Sevilla
Country [55] 0 0
Switzerland
State/province [55] 0 0
Lausanne
Country [56] 0 0
Switzerland
State/province [56] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biotronik AG
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Baim Institute for Clinical Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Medstar Health Research Institute
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus
Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or
restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent
system.
Trial website
https://clinicaltrials.gov/show/NCT02389946
Trial related presentations / publications
Doros G, Massaro JM, Kandzari DE, Waksman R, Koolen JJ, Cutlip DE, Mauri L. Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach. Am Heart J. 2017 Nov;193:35-45. doi: 10.1016/j.ahj.2017.08.001. Epub 2017 Aug 5.
Public notes

Contacts
Principal investigator
Name 0 0
Ron Waksman, MD
Address 0 0
Medstar Washington Hospital Center
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
Other publications