A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344653
• Other study ID #: MDT17054RES007
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: October 9, 2020

Study information

• Verified date: December 2020
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 9, 2020
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
• Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

Locations

Country	Name	City	State
Australia	Adelaide Cardiology	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Bundaberg Cardiology - Friendly Society Private Hospital	Bundaberg	Queensland
Australia	Cairns Hospital	Cairns	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Saint Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH - Universitätsklinikum Graz	Graz
Austria	A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck	Innsbruck
Austria	Allgemeines Krankenhaus - Universitätskliniken Wien	Wien
Belgium	C.H.U. de Charleroi	Charleroi
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Belgium	CHU de Liège - Hôpital du Sart Tilman	Liège
Bulgaria	Acibadem City Clinic	Sofia
France	Clinique Axium	Aix-en-Provence
France	Hôpital Privé Jacques Cartier	Massy
Hong Kong	Queen Elizabeth Hospital (Hong Kong)	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Ireland	Galway University Hospitals - University Hospital Galway (UHG)	Galway
Italy	Presidio Ospedaliero Ferrarotto Alessi	Catania
Italy	Centro Cardiologico Monzino	Milano
Italy	San Raffaele Scientific Institute	Milano
Italy	Umberto I - Policlinico di Roma	Roma
Italy	Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini	Seriate	Bergamo
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Latvia	Paula Stradina Kliniska universitates slimnica	Riga
Latvia	Riga East University Hospital	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno Klinikos	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Malaysia	Hospital Serdang	Kajang	Selangor Darul Ehsan
Malaysia	Queen Elizabeth II Hospital	Kota Kinabalu	Sabah
Malaysia	Sarawak Heart Centre	Kota Kinabalu
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Malaysia	Sarawak Heart Centre	Kuching	Sarawak
Netherlands	HagaZiekenhuis - Locatie Leyweg	Den Haag
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Zuyderland Medisch Centrum Heerlen	Heerlen
Netherlands	Maastricht Universitair Medisch Centrum (MUMC)	Maastricht
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo	Venlo
Netherlands	Isala Zwolle	Zwolle
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Newtown
Norway	Oslo Universitetssykehus-Ullevål Universitetssykehus	Oslo
Norway	Stavanger Universitetssjukehus - Helse Stavanger HF	Stavanger
Poland	Górnoslaskie Centrum Medyczne im prof Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach	Katowice
Poland	Miedziowe Centrum Zdrowia	Lubin
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Slovakia	Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s	Banska Bystrica
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Bellvitge	Barcelona
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander
Sweden	Gävle sjukhus	Gävle
Sweden	Universitetssjukhuset Örebro	Örebro
Sweden	Karolinska University Hospital in Solna	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	Västmanlands Sjukhus	Västerås
Switzerland	Inselspital - Universitätsspital Bern	Bern
Switzerland	Cardiocentro Ticino	Lugano
Thailand	Siriraj Hospital	Bangkok
United Kingdom	Cardiff and Vale University Health Board - University Hospital of Wales (UHW)	Cardiff
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter
United Kingdom	Golden Jubilee National Hospital - NHS Trust	Glasgow
United Kingdom	Royal Free Hospital	London
United Kingdom	The James Cook University Hospital - South Tees Hospitals NHS	Middlesbrough
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Queen Alexandra Hospital	Portsmouth

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  France,  Hong Kong,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Netherlands,  New Zealand,  Norway,  Poland,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	2 year post-procedure
Secondary	Cardiac Death	All deaths including cardiac death	2 year post- procedure
Secondary	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
Secondary	Myocardial Infarction	All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)	2 year post-procedure
Secondary	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
Secondary	Revascularization	All revascularizations (TLR, TVR and non-TVR)	2 year post-procedure
Secondary	Stent Thrombosis	Stent thrombosis (per Academic Research Consortium (ARC) definition)	2 year post-procedure
Secondary	Bleeding	Bleeding per BARC criteria	2 year post-procedure
Secondary	Stroke	Stroke	2 year post-procedure
Secondary	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
Secondary	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