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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System | Device | Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 year post-procedure |
| Procedure Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Windecker, MD | Bern University Hospital, Bern, Switzerland | Principal Investigator |
| Azeem Latib, MD | San Raffaele Scientific Institute, Milan, Italy | Principal Investigator |
| Elvin Kedhi, MD | Isala Zwolle, Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Saint Leonards | New South Wales | 2065 | Australia | ||
| Royal Brisbane and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38626080 | Derived | 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. | |
| 37550123 |
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Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.
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Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).
| Biosensors BioFreedom BA9 Drug Coated Coronary Stent | Device | Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT |
|
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.
| 2 year post-procedure |
| Cardiac Death | All deaths including cardiac death | 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 | 2 year post- procedure |
| Myocardial Infarction | All myocardial infarction including Target Vessel Myocardial Infarction (TVMI) | 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. | 2 year post-procedure |
| Revascularization | All revascularizations (TLR, TVR and non-TVR) | 2 year post-procedure |
| Stent Thrombosis | Stent thrombosis (per Academic Research Consortium (ARC) definition) | 2 year post-procedure |
| Bleeding | Bleeding per BARC criteria | 2 year post-procedure |
| Stroke | Stroke | 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 | 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. | 2 year post-procedure |
| Brisbane |
| Queensland |
| 4029 |
| Australia |
| Bundaberg Cardiology - Friendly Society Private Hospital | Bundaberg | Queensland | 4670 | Australia |
| Cairns Hospital | Cairns | Queensland | 4870 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Adelaide Cardiology | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Saint Vincent's Hospital (Melbourne) | Fitzroy | Victoria | 3065 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| LKH - Universitätsklinikum Graz | Graz | 8036 | Austria |
| A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck | Innsbruck | 6020 | Austria |
| Allgemeines Krankenhaus - Universitätskliniken Wien | Vienna | 1090 | Austria |
| C.H.U. de Charleroi | Charleroi | 6042 | Belgium |
| UZ Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Liège - Hôpital du Sart Tilman | Liège | 4000 | Belgium |
| Acibadem City Clinic | Sofia | 1700 | Bulgaria |
| Clinique Axium | Aix-en-Provence | 13097 | France |
| Hôpital Privé Jacques Cartier | Massy | 91300 | France |
| Queen Elizabeth Hospital (Hong Kong) | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Galway University Hospitals - University Hospital Galway (UHG) | Galway | Ireland |
| Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini | Seriate | Bergamo | 24068 | Italy |
| Presidio Ospedaliero Ferrarotto Alessi | Catania | 95124 | Italy |
| San Raffaele Scientific Institute | Milan | 20132 | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Umberto I - Policlinico di Roma | Roma | 00161 | Italy |
| Paula Stradina Kliniska universitates slimnica | Riga | 1002 | Latvia |
| Riga East University Hospital | Riga | LV-1079 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos | Kaunas | 50009 | Lithuania |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | 08661 | Lithuania |
| Queen Elizabeth II Hospital | Kota Kinabalu | Sabah | 88300 | Malaysia |
| Sarawak Heart Centre | Kuching | Sarawak | 93586 | Malaysia |
| Hospital Serdang | Kajang | Selangor | 43000 | Malaysia |
| Sarawak Heart Centre | Kota Kinabalu | 94300 | Malaysia |
| Institut Jantung Negara - National Heart Institute | Kuala Lumpur | 50400 | Malaysia |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| Zuyderland Medisch Centrum Heerlen | Heerlen | 6419 PC | Netherlands |
| Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | 6229 HX | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| HagaZiekenhuis - Locatie Leyweg | The Hague | 2545 CH | Netherlands |
| VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo | Venlo | 5912 BL | Netherlands |
| Isala Zwolle | Zwolle | 8025 AB | Netherlands |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Waikato Hospital | Hamilton | New Zealand |
| Wellington Hospital | Newtown | 6021 | New Zealand |
| Oslo Universitetssykehus-Ullevål Universitetssykehus | Oslo | 0450 | Norway |
| Stavanger Universitetssjukehus - Helse Stavanger HF | Stavanger | 4011 | Norway |
| Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40-635 | Poland |
| Miedziowe Centrum Zdrowia | Lubin | 59-301 | Poland |
| Szpital Kliniczny Przemienienia Panskiego | Poznan | 61-848 | Poland |
| National University Hospital | Singapore | 119074 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banská Bystrica | 97401 | Slovakia |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Seoul Saint Mary's Hospital | Seoul | 137-701 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 220-701 | South Korea |
| Hospital Clínico Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Gävle sjukhus | Gävle | 801 88 | Sweden |
| Universitetssjukhuset Örebro | Örebro | 701 85 | Sweden |
| Södersjukhuset | Stockholm | 118 83 | Sweden |
| Karolinska University Hospital in Solna | Stockholm | 171 76 | Sweden |
| Västmanlands Sjukhus | Västerås | 721 89 | Sweden |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| Cardiocentro Ticino | Lugano | 6900 | Switzerland |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Cardiff and Vale University Health Board - University Hospital of Wales (UHW) | Cardiff | CF14 4XW | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| Golden Jubilee National Hospital - NHS Trust | Glasgow | G81 4HX | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| The James Cook University Hospital - South Tees Hospitals NHS | Middlesbrough | TS4 3BW | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Derived |
| Toth 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. |
| 35680195 | Derived | 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. |
| 32050061 | Derived | 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. |
| 31203158 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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