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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04137510




Registration number
NCT04137510
Ethics application status
Date submitted
22/10/2019
Date registered
24/10/2019

Titles & IDs
Public title
Bioflow-DAPT Study
Scientific title
A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
Secondary ID [1] 0 0
C1703
Universal Trial Number (UTN)
Trial acronym
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
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous coronary intervention

Experimental: Orsiro -

Active comparator: Resolute Onyx -


Treatment: Devices: Percutaneous coronary intervention
It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
Timepoint [1] 0 0
12 months post-procedure
Secondary outcome [1] 0 0
Rate of definite/probable stent thrombosis according to the ARC definition
Timepoint [1] 0 0
until 12 months post-procedure
Secondary outcome [2] 0 0
Rate of MACCE
Timepoint [2] 0 0
until 12 months post-procedure
Secondary outcome [3] 0 0
Rate of MACE
Timepoint [3] 0 0
until 12 months post-procedure
Secondary outcome [4] 0 0
Rate of cardiac death or MI
Timepoint [4] 0 0
until 12 months post-procedure
Secondary outcome [5] 0 0
Rate of all-cause death, cardiac, non-cardiac
Timepoint [5] 0 0
until 12 months post-procedure
Secondary outcome [6] 0 0
Rate of stroke, ischemic and hemorrhagic
Timepoint [6] 0 0
until 12 months post-procedure
Secondary outcome [7] 0 0
Rate of clinically-indicated TVR
Timepoint [7] 0 0
until 12 months post-procedure
Secondary outcome [8] 0 0
Rate of clinically-indicated Target Lesion Revascularization (TLR)
Timepoint [8] 0 0
until 12 months post-procedure
Secondary outcome [9] 0 0
Rate of Target Vessel Failure (TVF)
Timepoint [9] 0 0
until 12 months post-procedure
Secondary outcome [10] 0 0
Rate of target lesion failure (TLF)
Timepoint [10] 0 0
until 12 months post-procedure
Secondary outcome [11] 0 0
Rate of bleeding according to BARC definition
Timepoint [11] 0 0
until 12 months post-procedure
Secondary outcome [12] 0 0
Rate of bleeding according to GUSTO definition
Timepoint [12] 0 0
until 12 months post-procedure
Secondary outcome [13] 0 0
Rate of bleeding according to TIMI definition
Timepoint [13] 0 0
until 12 months post-procedure
Secondary outcome [14] 0 0
Rate of Device success
Timepoint [14] 0 0
until 12 months post-procedure
Secondary outcome [15] 0 0
Rate of Procedure success
Timepoint [15] 0 0
until 12 months post-procedure

Eligibility
Key inclusion criteria
1. Subject is acceptable candidate for treatment with a DES
2. Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:

1. = 75 years of age
2. Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent)
3. Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
4. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
5. Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
6. Baseline thrombocytopenia defined as a platelet count <100,000/mm3
7. History of stroke (ischemic or hemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenous malformation
8. History of hospitalization for bleeding within the previous 12 months
9. Chronic clinically significant bleeding diathesis
10. Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
11. Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
12. Nondeferrable major surgery on DAPT
13. Recent major surgery or major trauma within 30 days before PCI
14. Precise DAPT score = 25
3. Subject is = 18 years or the minimum age required for legal adult consent in the country of enrollment
4. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
5. Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month
6. Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
2. Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media
3. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
4. 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure
5. Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure Note - planned staged procedure at the time of index procedure is not allowed
7. Active bleeding at the time of inclusion
8. Subject with a current medical condition with a life expectancy of less than 12 months
9. Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following the index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
10. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
11. In the investigator's opinion, subject will not be able to comply with the follow-up requirements
12. Subjects who need an impartial witness to give an informed consent

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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2022
Sample size
Target
Accrual to date
Final
1948
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Genk
Country [5] 0 0
Belgium
State/province [5] 0 0
Roeselare
Country [6] 0 0
Belgium
State/province [6] 0 0
Woluwe-Saint-Lambert
Country [7] 0 0
Denmark
State/province [7] 0 0
Hellerup
Country [8] 0 0
Denmark
State/province [8] 0 0
Roskilde
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
Lille
Country [11] 0 0
France
State/province [11] 0 0
Massy
Country [12] 0 0
France
State/province [12] 0 0
Nîmes
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
France
State/province [16] 0 0
Tours
Country [17] 0 0
Germany
State/province [17] 0 0
Bad Segeberg
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Essen
Country [20] 0 0
Germany
State/province [20] 0 0
Friedrichshafen
Country [21] 0 0
Germany
State/province [21] 0 0
Neuss
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Hong Kong
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Shatin
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Kaposvár
Country [26] 0 0
Hungary
State/province [26] 0 0
Pécs
Country [27] 0 0
Italy
State/province [27] 0 0
Catania
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Pavia
Country [30] 0 0
Italy
State/province [30] 0 0
Torrette
Country [31] 0 0
Latvia
State/province [31] 0 0
Engure
Country [32] 0 0
Latvia
State/province [32] 0 0
Riga
Country [33] 0 0
Malaysia
State/province [33] 0 0
Kuala Lumpur
Country [34] 0 0
Netherlands
State/province [34] 0 0
Den Haag
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
Poland
State/province [36] 0 0
Krakow
Country [37] 0 0
Poland
State/province [37] 0 0
Lubin
Country [38] 0 0
Singapore
State/province [38] 0 0
Singapore
Country [39] 0 0
Spain
State/province [39] 0 0
Santander
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Spain
State/province [41] 0 0
Vitoria
Country [42] 0 0
Switzerland
State/province [42] 0 0
Genève
Country [43] 0 0
Switzerland
State/province [43] 0 0
Lausanne
Country [44] 0 0
Switzerland
State/province [44] 0 0
Lugano
Country [45] 0 0
Switzerland
State/province [45] 0 0
Morges
Country [46] 0 0
Switzerland
State/province [46] 0 0
Zürich
Country [47] 0 0
Thailand
State/province [47] 0 0
Bangkok

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marco Valgimigli, Prof. Dr.
Address 0 0
Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04137510