Back to resultsA Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients (Onyx ONE)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
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, 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
Sites / Locations
- Royal North Shore Hospital
- Royal Brisbane and Women's Hospital
- Bundaberg Cardiology - Friendly Society Private Hospital
- Cairns Hospital
- The Prince Charles Hospital
- Princess Alexandra Hospital
- Adelaide Cardiology
- Flinders Medical Centre
- Saint Vincent's Hospital (Melbourne)
- The Alfred Hospital
- Fiona Stanley Hospital
- LKH - Universitätsklinikum Graz
- A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
- Allgemeines Krankenhaus - Universitätskliniken Wien
- C.H.U. de Charleroi
- UZ Leuven - Campus Gasthuisberg
- CHU de Liège - Hôpital du Sart Tilman
- Acibadem City Clinic
- Clinique Axium
- Hôpital Privé Jacques Cartier
- Queen Elizabeth Hospital (Hong Kong)
- Queen Mary Hospital
- Galway University Hospitals - University Hospital Galway (UHG)
- Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
- Presidio Ospedaliero Ferrarotto Alessi
- San Raffaele Scientific Institute
- Centro Cardiologico Monzino
- Umberto I - Policlinico di Roma
- Keimyung University Dongsan Medical Center
- Chonnam National University Hospital
- Seoul National University Bundang Hospital
- Severance Hospital
- Seoul National University Hospital
- Samsung Medical Center
- Seoul Saint Mary's Hospital
- Asan Medical Center
- Wonju Severance Christian Hospital
- Paula Stradina Kliniska universitates slimnica
- Riga East University Hospital
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
- Vilnius University Hospital Santariskiu Klinikos
- Queen Elizabeth II Hospital
- Sarawak Heart Centre
- Hospital Serdang
- Sarawak Heart Centre
- Institut Jantung Negara - National Heart Institute
- HagaZiekenhuis - Locatie Leyweg
- Universitair Medisch Centrum Groningen
- Zuyderland Medisch Centrum Heerlen
- Maastricht Universitair Medisch Centrum (MUMC)
- St. Antonius Ziekenhuis
- VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
- Isala Zwolle
- Auckland City Hospital
- Waikato Hospital
- Waikato Hospital
- Wellington Hospital
- Oslo Universitetssykehus-Ullevål Universitetssykehus
- Stavanger Universitetssjukehus - Helse Stavanger HF
- Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
- Miedziowe Centrum Zdrowia
- Szpital Kliniczny Przemienienia Panskiego
- National University Hospital
- Tan Tock Seng Hospital
- Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
- Hospital Clínico Universitario Virgen de la Arrixaca
- Hospital Universitario de Canarias
- Hospital General Universitario de Alicante
- Hospital del Mar
- Hospital Universitari Bellvitge
- Hospital Universitario La Paz
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Marques de Valdecilla
- Gävle sjukhus
- Södersjukhuset
- Karolinska University Hospital in Solna
- Västmanlands Sjukhus
- Universitetssjukhuset Örebro
- Inselspital - Universitätsspital Bern
- Cardiocentro Ticino
- Siriraj Hospital
- Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
- Royal Infirmary of Edinburgh
- Royal Devon and Exeter NHS Foundation Trust
- Golden Jubilee National Hospital - NHS Trust
- Royal Free Hospital
- The James Cook University Hospital - South Tees Hospitals NHS
- The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
- Queen Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Resolute Onyx stent
BioFreedom stent
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Cardiac Death
All deaths including cardiac death
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
Myocardial Infarction
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
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.
Revascularization
All revascularizations (TLR, TVR and non-TVR)
Stent Thrombosis
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Bleeding
Bleeding per BARC criteria
Stroke
Stroke
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03344653
Brief Title
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Acronym
Onyx ONE
Official Title
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
October 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resolute Onyx stent
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BioFreedom stent
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Intervention Description
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
Intervention Type
Device
Intervention Name(s)
Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Intervention Description
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
Primary Outcome Measure Information:
Title
Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis
Description
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
Time Frame
1 year post-procedure
Secondary Outcome Measure Information:
Title
Target Lesion Failure
Description
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
Time Frame
2 year post-procedure
Title
Procedure Success
Description
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.
Time Frame
2 year post-procedure
Title
Cardiac Death
Description
All deaths including cardiac death
Time Frame
2 year post- procedure
Title
Major Cardiac Event
Description
Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Time Frame
2 year post- procedure
Title
Myocardial Infarction
Description
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Time Frame
2 year post-procedure
Title
Target Vessel Failure
Description
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.
Time Frame
2 year post-procedure
Title
Revascularization
Description
All revascularizations (TLR, TVR and non-TVR)
Time Frame
2 year post-procedure
Title
Stent Thrombosis
Description
Stent thrombosis (per Academic Research Consortium (ARC) definition)
Time Frame
2 year post-procedure
Title
Bleeding
Description
Bleeding per BARC criteria
Time Frame
2 year post-procedure
Title
Stroke
Description
Stroke
Time Frame
2 year post-procedure
Title
Lesion Success
Description
The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
Time Frame
2 year post-procedure
Title
Device success
Description
Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
Time Frame
2 year post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD
Organizational Affiliation
Bern University Hospital, Bern, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azeem Latib, MD
Organizational Affiliation
San Raffaele Scientific Institute, Milan, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elvin Kedhi, MD
Organizational Affiliation
Isala Zwolle, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Bundaberg Cardiology - Friendly Society Private Hospital
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Adelaide Cardiology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Saint Vincent's Hospital (Melbourne)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
LKH - Universitätsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Allgemeines Krankenhaus - Universitätskliniken Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
C.H.U. de Charleroi
City
Charleroi
ZIP/Postal Code
6042
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège - Hôpital du Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Acibadem City Clinic
City
Sofia
ZIP/Postal Code
1700
Country
Bulgaria
Facility Name
Clinique Axium
City
Aix-en-Provence
ZIP/Postal Code
13097
Country
France
Facility Name
Hôpital Privé Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Queen Elizabeth Hospital (Hong Kong)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Galway University Hospitals - University Hospital Galway (UHG)
City
Galway
Country
Ireland
Facility Name
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
City
Seriate
State/Province
Bergamo
ZIP/Postal Code
24068
Country
Italy
Facility Name
Presidio Ospedaliero Ferrarotto Alessi
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
San Raffaele Scientific Institute
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Umberto I - Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Paula Stradina Kliniska universitates slimnica
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga East University Hospital
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Queen Elizabeth II Hospital
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88300
Country
Malaysia
Facility Name
Sarawak Heart Centre
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Sarawak Heart Centre
City
Kota Kinabalu
ZIP/Postal Code
94300
Country
Malaysia
Facility Name
Institut Jantung Negara - National Heart Institute
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
HagaZiekenhuis - Locatie Leyweg
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum Heerlen
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum (MUMC)
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Isala Zwolle
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Oslo Universitetssykehus-Ullevål Universitetssykehus
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Stavanger Universitetssjukehus - Helse Stavanger HF
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Miedziowe Centrum Zdrowia
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Gävle sjukhus
City
Gävle
ZIP/Postal Code
801 88
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska University Hospital in Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Västmanlands Sjukhus
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Inselspital - Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital - NHS Trust
City
Glasgow
ZIP/Postal Code
G81 4HX
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The James Cook University Hospital - South Tees Hospitals NHS
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35680195
Citation
Windecker 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.
Results Reference
derived
PubMed Identifier
32050061
Citation
Windecker 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.
Results Reference
derived
PubMed Identifier
31203158
Citation
Kedhi 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.
Results Reference
derived
Learn more about this trial
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
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