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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03344653




Registration number
NCT03344653
Ethics application status
Date submitted
20/10/2017
Date registered
13/11/2017
Date last updated
10/10/2018

Titles & IDs
Public title
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Scientific title
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Secondary ID [1] 0 0
MDT17054RES007
Universal Trial Number (UTN)
Trial acronym
Onyx ONE
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 - Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Treatment: Devices - Biosensors BioFreedom BA9 Drug Coated Coronary Stent

Active Comparator: Resolute Onyx stent - Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.

Active Comparator: BioFreedom stent - Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.


Treatment: Devices: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT

Treatment: Devices: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

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

Outcomes
Primary outcome [1] 0 0
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis - Powered for non-inferiority against BioFreedom (control), is a composite of cardiac death, myocardial infarction and definite/probable stent thrombosis. The combined clinical outcome of cardiac death, MI or stent thrombosis
Timepoint [1] 0 0
1 year post-procedure
Secondary outcome [1] 0 0
Target Lesion Failure - Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical methods
Timepoint [1] 0 0
2 year post-procedure
Secondary outcome [2] 0 0
Procedure Success - Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
Timepoint [2] 0 0
2 year post-procedure
Secondary outcome [3] 0 0
Cardiac Death - All deaths including cardiac death
Timepoint [3] 0 0
2 year post- procedure
Secondary outcome [4] 0 0
Major Cardiac Event - Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Timepoint [4] 0 0
2 year post- procedure
Secondary outcome [5] 0 0
Myocardial Infarction - All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Timepoint [5] 0 0
2 year post-procedure
Secondary outcome [6] 0 0
Target Vessel Failure - Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
Timepoint [6] 0 0
2 year post-procedure
Secondary outcome [7] 0 0
Revascularization - All revascularizations (TLR, TVR and non-TVR)
Timepoint [7] 0 0
2 year post-procedure
Secondary outcome [8] 0 0
Stent Thrombosis - Stent thrombosis (per Academic Research Consortium (ARC) definition)
Timepoint [8] 0 0
2 year post-procedure
Secondary outcome [9] 0 0
Bleeding - Bleeding per BARC criteria
Timepoint [9] 0 0
2 year post-procedure
Secondary outcome [10] 0 0
Stroke - Stroke
Timepoint [10] 0 0
2 year post-procedure
Secondary outcome [11] 0 0
Lesion Success - The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Timepoint [11] 0 0
2 year post-procedure
Secondary outcome [12] 0 0
Device success - Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Timepoint [12] 0 0
2 year post-procedure

Eligibility
Key inclusion criteria
- Age = 75 years old

- Any prior documented intracerebral bleed

- Any documented stroke in the last 12 months

- Hospital admission for bleeding during the prior 12 months

- Non-skin cancer diagnosed or treated =3 years

- Planned surgery within the next 12 months

- Renal failure defined as: Creatinine clearance <40 ml/min

- Thrombocytopenia (PLT <100,000/mm3)

- Severe chronic liver disease defined as: subjects who have developed any of the
following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant and breastfeeding women

- Subjects requiring a planned PCI procedure after 1 month of index procedure

- Active bleeding at the time of inclusion

- Cardiogenic shock

- A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin,
P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its
derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer
coatings (eg, BioLinxâ„¢), stainless steel (or other metal ions found in 316L stainless
steel), zinc, or a sensitivity to contrast media, which cannot be adequately
pre-medicated.

- PCI during the previous 6 months for a lesion other than the target lesion of the
index procedure

- Participation in another clinical study within 12 months after index procedure

- Subjects with life expectancy of less than 2 years

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 receiving the treatment/s


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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Bundaberg Cardiology - Friendly Society Private Hospital - Bundaberg
Recruitment hospital [4] 0 0
Cairns Hospital - Cairns
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Adelaide Cardiology - Adelaide
Recruitment hospital [8] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [9] 0 0
Saint Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4670 - Bundaberg
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Charleroi
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
France
State/province [8] 0 0
Aix-en-Provence
Country [9] 0 0
France
State/province [9] 0 0
Massy
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Ireland
State/province [11] 0 0
Galway
Country [12] 0 0
Italy
State/province [12] 0 0
Bergamo
Country [13] 0 0
Italy
State/province [13] 0 0
Catania
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Italy
State/province [15] 0 0
Roma
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daegu
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Gwangju
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seongnam-si
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Wonju
Country [21] 0 0
Latvia
State/province [21] 0 0
Riga
Country [22] 0 0
Lithuania
State/province [22] 0 0
Kaunas
Country [23] 0 0
Lithuania
State/province [23] 0 0
Vilnius
Country [24] 0 0
Malaysia
State/province [24] 0 0
Sabah
Country [25] 0 0
Malaysia
State/province [25] 0 0
Sarawak
Country [26] 0 0
Malaysia
State/province [26] 0 0
Selangor Darul Ehsan
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kota Kinabalu
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Netherlands
State/province [29] 0 0
Den Haag
Country [30] 0 0
Netherlands
State/province [30] 0 0
Groningen
Country [31] 0 0
Netherlands
State/province [31] 0 0
Heerlen
Country [32] 0 0
Netherlands
State/province [32] 0 0
Maastricht
Country [33] 0 0
Netherlands
State/province [33] 0 0
Nieuwegein
Country [34] 0 0
Netherlands
State/province [34] 0 0
Venlo
Country [35] 0 0
Netherlands
State/province [35] 0 0
Zwolle
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
New Zealand
State/province [37] 0 0
Hamilton
Country [38] 0 0
New Zealand
State/province [38] 0 0
Newtown
Country [39] 0 0
Norway
State/province [39] 0 0
Oslo
Country [40] 0 0
Norway
State/province [40] 0 0
Stavanger
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Lubin
Country [43] 0 0
Poland
State/province [43] 0 0
Poznan
Country [44] 0 0
Singapore
State/province [44] 0 0
Singapore
Country [45] 0 0
Slovakia
State/province [45] 0 0
Banska Bystrica
Country [46] 0 0
Spain
State/province [46] 0 0
Murcia
Country [47] 0 0
Spain
State/province [47] 0 0
Tenerife
Country [48] 0 0
Spain
State/province [48] 0 0
Alicante
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Salamanca
Country [52] 0 0
Spain
State/province [52] 0 0
Santander
Country [53] 0 0
Sweden
State/province [53] 0 0
Gävle
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholm
Country [55] 0 0
Sweden
State/province [55] 0 0
Västerås
Country [56] 0 0
Sweden
State/province [56] 0 0
Örebro
Country [57] 0 0
Switzerland
State/province [57] 0 0
Bern
Country [58] 0 0
Switzerland
State/province [58] 0 0
Lugano
Country [59] 0 0
Thailand
State/province [59] 0 0
Bangkok
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cardiff
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Edinburgh
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Exeter
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Glasgow
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Middlesbrough
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Newcastle Upon Tyne
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the clinical safety and effectiveness of the
Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable
for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following
stent implantation.
Trial website
https://clinicaltrials.gov/show/NCT03344653
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephan Windecker, MD
Address 0 0
Bern University Hospital, Bern, 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

No data has been provided for results reporting
Summary results
Other publications