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

Status: Completed
Location: See all (89) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Adelaide Cardiology
Adelaide
Flinders Medical Centre
Bedford Park
Royal Brisbane and Women's Hospital
Brisbane
Bundaberg Cardiology - Friendly Society Private Hospital
Bundaberg
Cairns Hospital
Cairns
The Prince Charles Hospital
Chermside
Saint Vincent's Hospital (Melbourne)
Fitzroy
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Murdoch
Royal North Shore Hospital
Saint Leonards
Princess Alexandra Hospital
Woolloongabba
Austria
LKH - Universitätsklinikum Graz
Graz
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck
Allgemeines Krankenhaus - Universitätskliniken Wien
Wien
Belgium
C.H.U. de Charleroi
Charleroi
UZ Leuven - Campus Gasthuisberg
Leuven
CHU de Liège - Hôpital du Sart Tilman
Liège
Bulgaria
Acibadem City Clinic
Sofia
France
Clinique Axium
Aix-en-provence
Hôpital Privé Jacques Cartier
Massy
Hong Kong Special Administrative Region
Queen Elizabeth Hospital (Hong Kong)
Hong Kong
Queen Mary Hospital
Hong Kong
Ireland
Galway University Hospitals - University Hospital Galway (UHG)
Galway
Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania
Centro Cardiologico Monzino
Milano
San Raffaele Scientific Institute
Milano
Umberto I - Policlinico di Roma
Roma
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate
Latvia
Paula Stradina Kliniska universitates slimnica
Riga
Riga East University Hospital
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas
Vilnius University Hospital Santariskiu Klinikos
Vilnius
Malaysia
Hospital Serdang
Kajang
Queen Elizabeth II Hospital
Kota Kinabalu
Sarawak Heart Centre
Kota Kinabalu
Institut Jantung Negara - National Heart Institute
Kuala Lumpur
Sarawak Heart Centre
Kuching
Netherlands
HagaZiekenhuis - Locatie Leyweg
Den Haag
Universitair Medisch Centrum Groningen
Groningen
Zuyderland Medisch Centrum Heerlen
Heerlen
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht
St. Antonius Ziekenhuis
Nieuwegein
VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo
Isala Zwolle
Zwolle
New Zealand
Auckland City Hospital
Auckland
Waikato Hospital
Hamilton
Waikato Hospital
Hamilton
Wellington Hospital
Newtown
Norway
Oslo Universitetssykehus-Ullevål Universitetssykehus
Oslo
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger
Poland
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice
Miedziowe Centrum Zdrowia
Lubin
Szpital Kliniczny Przemienienia Panskiego
Poznań
Republic of Korea
Keimyung University Dongsan Medical Center
Daegu
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul Saint Mary's Hospital
Seoul
Severance Hospital
Seoul
Wonju Severance Christian Hospital
Wonju
Singapore
National University Hospital
Singapore
Tan Tock Seng Hospital
Singapore
Slovakia
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banska Bystrica
Spain
Hospital General Universitario de Alicante
Alicante
Hospital del Mar
Barcelona
Hospital Universitari Bellvitge
Barcelona
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar
Hospital Universitario de Canarias
La Laguna
Hospital Universitario La Paz
Madrid
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital Universitario Marques de Valdecilla
Santander
Sweden
Gävle sjukhus
Gävle
Universitetssjukhuset Örebro
Örebro
Karolinska University Hospital in Solna
Stockholm
Södersjukhuset
Stockholm
Västmanlands Sjukhus
Västerås
Switzerland
Inselspital - Universitätsspital Bern
Bern
Cardiocentro Ticino
Lugano
Thailand
Siriraj Hospital
Bangkok
United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
Cardiff
Royal Infirmary of Edinburgh
Edinburgh
Royal Devon and Exeter NHS Foundation Trust
Exeter
Golden Jubilee National Hospital - NHS Trust
Glasgow
Royal Free Hospital
London
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne
Queen Alexandra Hospital
Portsmouth
Time Frame
Start Date: 2017-11-02
Completion Date: 2020-10-09
Participants
Target number of participants: 2000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medtronic Vascular

This content was sourced from clinicaltrials.gov

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