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

December 1, 2020 updated by: Medtronic Vascular

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Bundaberg, Queensland, Australia, 4670
        • Bundaberg Cardiology - Friendly Society Private Hospital
      • Cairns, Queensland, Australia, 4870
        • Cairns Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Adelaide Cardiology
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Saint Vincent's Hospital (Melbourne)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Graz, Austria, 8036
        • LKH - Universitätsklinikum Graz
      • Innsbruck, Austria, 6020
        • A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
      • Wien, Austria, 1090
        • Allgemeines Krankenhaus - Universitätskliniken Wien
  • Belgium
      • Charleroi, Belgium, 6042
        • C.H.U. de Charleroi
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
      • Liège, Belgium, 4000
        • CHU de Liège - Hôpital du Sart Tilman
  • Bulgaria
      • Sofia, Bulgaria, 1700
        • Acibadem City Clinic
  • France
      • Aix-en-Provence, France, 13097
        • Clinique Axium
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital (Hong Kong)
  • Ireland
      • Galway, Ireland
        • Galway University Hospitals - University Hospital Galway (UHG)
  • Italy
      • Catania, Italy, 95124
        • Presidio Ospedaliero Ferrarotto Alessi
      • Milano, Italy, 20132
        • San Raffaele Scientific Institute
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino
      • Roma, Italy, 00161
        • Umberto I - Policlinico di Roma
    • Bergamo
      • Seriate, Bergamo, Italy, 24068
        • Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 137-701
        • Seoul Saint Mary's Hospital
      • Wonju, Korea, Republic of, 220-701
        • Wonju Severance Christian Hospital
  • Latvia
      • Riga, Latvia, 1002
        • Paula Stradiņa klīniskā universitates slimnīca
      • Riga, Latvia, LV-1079
        • Riga East University Hospital
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health Sciences Kauno klinikos
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santariskiu Klinikos
  • Malaysia
      • Kota Kinabalu, Malaysia, 94300
        • Sarawak Heart Centre
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara - National Heart Institute
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia, 88300
        • Queen Elizabeth II Hospital
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak Heart Centre
    • Selangor Darul Ehsan
      • Kajang, Selangor Darul Ehsan, Malaysia, 43000
        • Hospital Serdang
  • Netherlands
      • Den Haag, Netherlands, 2545 CH
        • HagaZiekenhuis - Locatie Leyweg
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Heerlen, Netherlands, 6419 PC
        • Zuyderland Medisch Centrum Heerlen
      • Maastricht, Netherlands, 6229 HX
        • Maastricht Universitair Medisch Centrum (MUMC)
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
      • Zwolle, Netherlands, 8025 AB
        • Isala Zwolle
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand
        • Waikato Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Newtown, New Zealand, 6021
        • Wellington Hospital
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus-Ullevål Universitetssykehus
      • Stavanger, Norway, 4011
        • Stavanger Universitetssjukehus - Helse Stavanger HF
  • Poland
      • Katowice, Poland, 40-635
        • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
      • Lubin, Poland, 59-301
        • Miedziowe Centrum Zdrowia
      • Poznań, Poland, 61-848
        • Szpital Kliniczny Przemienienia Pańskiego
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • Stredoslovensky ustav srdcovych a cievnych chorob a.s
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
  • Sweden
      • Gävle, Sweden, 801 88
        • Gavle Sjukhus
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital in Solna
      • Västerås, Sweden, 721 89
        • Västmanlands sjukhus
      • Örebro, Sweden, 701 85
        • Universitetssjukhuset Örebro
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital - Universitätsspital Bern
      • Lugano, Switzerland, 6900
        • Cardiocentro Ticino
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Cardiff and Vale University Health Board - University Hospital of wales (UHW)
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter NHS Foundation Trust
      • Glasgow, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital - NHS Trust
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital - South Tees Hospitals NHS
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
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.
Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Target Lesion Failure
Time Frame: 2 year post-procedure
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
Time Frame: 2 year post-procedure
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
Time Frame: 2 year post- procedure
All deaths including cardiac death
2 year post- procedure
Major Cardiac Event
Time Frame: 2 year post- procedure
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
Time Frame: 2 year post-procedure
All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
2 year post-procedure
Target Vessel Failure
Time Frame: 2 year post-procedure
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
Time Frame: 2 year post-procedure
All revascularizations (TLR, TVR and non-TVR)
2 year post-procedure
Stent Thrombosis
Time Frame: 2 year post-procedure
Stent thrombosis (per Academic Research Consortium (ARC) definition)
2 year post-procedure
Bleeding
Time Frame: 2 year post-procedure
Bleeding per BARC criteria
2 year post-procedure
Stroke
Time Frame: 2 year post-procedure
Stroke
2 year post-procedure
Lesion Success
Time Frame: 2 year post-procedure
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
Time Frame: 2 year post-procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Vascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT17054RES007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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