Coronary Artery DiseaseOnyx ONENCT03344653
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
A study testing Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System and Biosensors BioFreedom BA9 Drug Coated Coronary Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 89 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System and Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 89 sitesin 23 countries
- Study dates
- 2 Nov 2017to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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, BioLinx™), 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
Trial locations and contacts
89 sites in 23 countries.
89 sites in 23 countries
Australia11 sites
Adelaide Cardiology
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Bundaberg Cardiology - Friendly Society Private Hospital
Bundaberg, Queensland, 4670
Cairns Hospital
Cairns, Queensland, 4870
The Prince Charles Hospital
Chermside, Queensland, 4032
Saint Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065
The Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
South Korea9 sites
Keimyung University Dongsan Medical Center
Daegu, 41931
Chonnam National University Hospital
Gwangju, 501-757
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Severance Hospital
Seoul, 03722
Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Seoul Saint Mary's Hospital
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
Wonju Severance Christian Hospital
Wŏnju, 220-701
Spain8 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital del Mar
Barcelona, 08003
Hospital Universitari Bellvitge
Barcelona, 08907
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario La Paz
Madrid, 28046
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, 39008
United Kingdom8 sites
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
Cardiff, CF14 4XW
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW
Golden Jubilee National Hospital - NHS Trust
Glasgow, G81 4HX
Royal Free Hospital
London, NW3 2QG
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough, TS4 3BW
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Netherlands7 sites
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Zuyderland Medisch Centrum Heerlen
Heerlen, 6419 PC
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, 6229 HX
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
HagaZiekenhuis - Locatie Leyweg
The Hague, 2545 CH
VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, 5912 BL
Isala Zwolle
Zwolle, 8025 AB
Italy5 sites
Presidio Ospedaliero Ferrarotto Alessi
Catania, 95124
San Raffaele Scientific Institute
Milan, 20132
Centro Cardiologico Monzino
Milan, 20138
Umberto I - Policlinico di Roma
Roma, 00161
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate, Bergamo, 24068
Malaysia5 sites
Hospital Serdang
Kajang, Selangor, 43000
Queen Elizabeth II Hospital
Kota Kinabalu, Sabah, 88300
Sarawak Heart Centre
Kota Kinabalu, 94300
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, 50400
Sarawak Heart Centre
Kuching, Sarawak, 93586
Sweden5 sites
Gävle sjukhus
Gävle, 801 88
Universitetssjukhuset Örebro
Örebro, 701 85
Södersjukhuset
Stockholm, 118 83
Karolinska University Hospital in Solna
Stockholm, 171 76
Västmanlands Sjukhus
Västerås, 721 89
New Zealand4 sites
Auckland City Hospital
Auckland, 1023
Waikato Hospital
Hamilton, 3240
Waikato Hospital
Hamilton
Wellington Hospital
Newtown, 6021
Austria3 sites
LKH - Universitätsklinikum Graz
Graz, 8036
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, 6020
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, 1090
Belgium3 sites
C.H.U. de Charleroi
Charleroi, 6042
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
CHU de Liège - Hôpital du Sart Tilman
Liège, 4000
Poland3 sites
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-635
Miedziowe Centrum Zdrowia
Lubin, 59-301
Szpital Kliniczny Przemienienia Panskiego
Poznan, 61-848
France2 sites
Clinique Axium
Aix-en-Provence, 13097
Hôpital Privé Jacques Cartier
Massy, 91300
Hong Kong2 sites
Queen Elizabeth Hospital (Hong Kong)
Hong Kong
Queen Mary Hospital
Hong Kong
Latvia2 sites
Paula Stradina Kliniska universitates slimnica
Riga, 1002
Riga East University Hospital
Riga, LV-1079
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50009
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
Norway2 sites
Oslo Universitetssykehus-Ullevål Universitetssykehus
Oslo, 0450
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, 4011
Singapore2 sites
National University Hospital
Singapore, 119074
Tan Tock Seng Hospital
Singapore, 308433
Switzerland2 sites
Inselspital - Universitätsspital Bern
Bern, 3010
Cardiocentro Ticino
Lugano, 6900
Ireland1 site
Galway University Hospitals - University Hospital Galway (UHG)
Galway
Slovakia1 site
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banská Bystrica, 97401
About this study
Official title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemDevice
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
Biosensors BioFreedom BA9 Drug Coated Coronary StentDevice
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
| Study group | Role | What they receive |
|---|---|---|
| Resolute Onyx stent | Active comparator | 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. Receives: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System |
| BioFreedom stent | Active comparator | 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. Receives: Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post-procedure
Secondary outcomes (12)
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
Measured: 2 year post-procedure
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.
Measured: 2 year post-procedure
Cardiac Death
All deaths including cardiac death
Measured: 2 year post- procedure
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
Measured: 2 year post- procedure
Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Measured: 2 year post-procedure
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.
Measured: 2 year post-procedure
Revascularization
All revascularizations (TLR, TVR and non-TVR)
Measured: 2 year post-procedure
Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Measured: 2 year post-procedure
Bleeding
Bleeding per BARC criteria
Measured: 2 year post-procedure
Stroke
Stroke
Measured: 2 year post-procedure
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
Measured: 2 year post-procedure
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.
Measured: 2 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start2 Nov 2017
- Primary completion27 Sep 2018
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Windecker, MD, Principal investigator, Bern University Hospital, Bern, SwitzerlandAzeem Latib, MD, Principal investigator, San Raffaele Scientific Institute, Milan, ItalyElvin Kedhi, MD, Principal investigator, Isala Zwolle, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344653
- Sponsor's protocol ID
- MDT17054RES007
- Acronym
- Onyx ONE
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2017
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
PubMed 38626080Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
PubMed 37550123Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Kahar Bin Abdul Ghapar A, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Ali ZA, Parke M, Lung TH, Stone GW; Onyx ONE Investigators. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010.
PubMed 35680195Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12.
PubMed 32050061Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.
PubMed 31203158
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
- ClinicalTrials.gov ID
- NCT03344653
- Acronym / sponsor ID
- Onyx ONE / MDT17054RES007
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.
| Arm | Type | Receives |
|---|---|---|
| Resolute Onyx stent | Active comparator | Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemSubjects 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. |
| BioFreedom stent | Active comparator | Device: Biosensors BioFreedom BA9 Drug Coated Coronary StentSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT | Device | Resolute Onyx stent |
| Biosensors BioFreedom BA9 Drug Coated Coronary StentBiosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT | Device | BioFreedom stent |
Primary outcome
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
Time frame: 1 year post-procedure
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
12 secondary outcomes
Target Lesion Failure
Time frame: 2 year post-procedure
Procedure Success
Time frame: 2 year post-procedure
Cardiac Death
Time frame: 2 year post- procedure
Major Cardiac Event
Time frame: 2 year post- procedure
Myocardial Infarction
Time frame: 2 year post-procedure
Target Vessel Failure
Time frame: 2 year post-procedure
Revascularization
Time frame: 2 year post-procedure
Stent Thrombosis
Time frame: 2 year post-procedure
Bleeding
Time frame: 2 year post-procedure
Stroke
Time frame: 2 year post-procedure
Lesion Success
Time frame: 2 year post-procedure
Device success
Time frame: 2 year post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Derived from this study: PubMed 38626080Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
- Derived from this study: PubMed 37550123Toth GG, Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Choi JW, Caputo R, Troquay R, Diderholm E, Singh S, Brar SS, Loussararian A, Chetcuti S, Tulli M, Stone GW, Lung TH, Mylotte D. Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging. Cardiovasc Revasc Med. 2024 Jan;58:60-67. doi: 10.1016/j.carrev.2023.07.016. Epub 2023 Jul 24.
- Derived from this study: PubMed 35680195Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Kahar Bin Abdul Ghapar A, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Ali ZA, Parke M, Lung TH, Stone GW; Onyx ONE Investigators. Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1153-1163. doi: 10.1016/j.jcin.2022.04.010.
- Derived from this study: PubMed 32050061Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12.
- Derived from this study: PubMed 31203158Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Windecker, MD principal investigator
Bern University Hospital, Bern, Switzerland
Azeem Latib, MD principal investigator
San Raffaele Scientific Institute, Milan, Italy
Elvin Kedhi, MD principal investigator
Isala Zwolle, Netherlands
89 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System and Biosensors BioFreedom BA9 Drug Coated Coronary Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 89 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Australia, South Korea, Spain, United Kingdom, Netherlands and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis (time frame: 1 year post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344653, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.