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

Sponsor
Medtronic Vascular (Industry)
Overall Status
Completed
CT.gov ID
NCT03344653
Collaborator
(none)
2,000
Enrollment
89
Locations
2
Arms
35.2
Actual Duration (Months)
22.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
  • Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.Prospective, multi-center, blinded, randomized, controlled study enrolling eligible subjects at global centers. The enrollment period is anticipated to be approximately 14 months.
Masking:
Single (Participant)
Masking Description:
Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx stent or the BioFreedom stent (control).
Primary Purpose:
Treatment
Official Title:
Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Actual Study Start Date :
Nov 2, 2017
Actual Primary Completion Date :
Sep 27, 2018
Actual Study Completion Date :
Oct 9, 2020

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Composite endpoint: Cardiac Death, Myocardial Infarction, or Stent Thrombosis [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

Secondary Outcome Measures

  1. Target Lesion Failure [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. Procedure Success [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.

  3. Cardiac Death [2 year post- procedure]

    All deaths including cardiac death

  4. Major Cardiac Event [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

  5. Myocardial Infarction [2 year post-procedure]

    All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

  6. Target Vessel Failure [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.

  7. Revascularization [2 year post-procedure]

    All revascularizations (TLR, TVR and non-TVR)

  8. Stent Thrombosis [2 year post-procedure]

    Stent thrombosis (per Academic Research Consortium (ARC) definition)

  9. Bleeding [2 year post-procedure]

    Bleeding per BARC criteria

  10. Stroke [2 year post-procedure]

    Stroke

  11. Lesion Success [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

  12. Device success [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal North Shore Hospital Saint Leonards New South Wales Australia 2065
2 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
3 Bundaberg Cardiology - Friendly Society Private Hospital Bundaberg Queensland Australia 4670
4 Cairns Hospital Cairns Queensland Australia 4870
5 The Prince Charles Hospital Chermside Queensland Australia 4032
6 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
7 Adelaide Cardiology Adelaide South Australia Australia 5000
8 Flinders Medical Centre Bedford Park South Australia Australia 5042
9 Saint Vincent's Hospital (Melbourne) Fitzroy Victoria Australia 3065
10 The Alfred Hospital Melbourne Victoria Australia 3004
11 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
12 LKH - Universitätsklinikum Graz Graz Austria 8036
13 A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck Innsbruck Austria 6020
14 Allgemeines Krankenhaus - Universitätskliniken Wien Wien Austria 1090
15 C.H.U. de Charleroi Charleroi Belgium 6042
16 UZ Leuven - Campus Gasthuisberg Leuven Belgium 3000
17 CHU de Liège - Hôpital du Sart Tilman Liège Belgium 4000
18 Acibadem City Clinic Sofia Bulgaria 1700
19 Clinique Axium Aix-en-Provence France 13097
20 Hôpital Privé Jacques Cartier Massy France 91300
21 Queen Elizabeth Hospital (Hong Kong) Hong Kong Hong Kong
22 Queen Mary Hospital Hong Kong Hong Kong
23 Galway University Hospitals - University Hospital Galway (UHG) Galway Ireland
24 Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini Seriate Bergamo Italy 24068
25 Presidio Ospedaliero Ferrarotto Alessi Catania Italy 95124
26 San Raffaele Scientific Institute Milano Italy 20132
27 Centro Cardiologico Monzino Milano Italy 20138
28 Umberto I - Policlinico di Roma Roma Italy 00161
29 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
30 Chonnam National University Hospital Gwangju Korea, Republic of 501-757
31 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 463-707
32 Severance Hospital Seoul Korea, Republic of 03722
33 Seoul National University Hospital Seoul Korea, Republic of 110-744
34 Samsung Medical Center Seoul Korea, Republic of 135-710
35 Seoul Saint Mary's Hospital Seoul Korea, Republic of 137-701
36 Asan Medical Center Seoul Korea, Republic of 138-736
37 Wonju Severance Christian Hospital Wonju Korea, Republic of 220-701
38 Paula Stradina Kliniska universitates slimnica Riga Latvia 1002
39 Riga East University Hospital Riga Latvia LV-1079
40 Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas Lithuania 50009
41 Vilnius University Hospital Santariskiu Klinikos Vilnius Lithuania 08661
42 Queen Elizabeth II Hospital Kota Kinabalu Sabah Malaysia 88300
43 Sarawak Heart Centre Kuching Sarawak Malaysia 93586
44 Hospital Serdang Kajang Selangor Darul Ehsan Malaysia 43000
45 Sarawak Heart Centre Kota Kinabalu Malaysia 94300
46 Institut Jantung Negara - National Heart Institute Kuala Lumpur Malaysia 50400
47 HagaZiekenhuis - Locatie Leyweg Den Haag Netherlands 2545 CH
48 Universitair Medisch Centrum Groningen Groningen Netherlands 9713 GZ
49 Zuyderland Medisch Centrum Heerlen Heerlen Netherlands 6419 PC
50 Maastricht Universitair Medisch Centrum (MUMC) Maastricht Netherlands 6229 HX
51 St. Antonius Ziekenhuis Nieuwegein Netherlands 3435 CM
52 VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo Venlo Netherlands 5912 BL
53 Isala Zwolle Zwolle Netherlands 8025 AB
54 Auckland City Hospital Auckland New Zealand 1023
55 Waikato Hospital Hamilton New Zealand 3240
56 Waikato Hospital Hamilton New Zealand
57 Wellington Hospital Newtown New Zealand 6021
58 Oslo Universitetssykehus-Ullevål Universitetssykehus Oslo Norway 0450
59 Stavanger Universitetssjukehus - Helse Stavanger HF Stavanger Norway 4011
60 Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach Katowice Poland 40-635
61 Miedziowe Centrum Zdrowia Lubin Poland 59-301
62 Szpital Kliniczny Przemienienia Panskiego Poznań Poland 61-848
63 National University Hospital Singapore Singapore 119074
64 Tan Tock Seng Hospital Singapore Singapore 308433
65 Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s Banska Bystrica Slovakia 97401
66 Hospital Clínico Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
67 Hospital Universitario de Canarias La Laguna Tenerife Spain 38320
68 Hospital General Universitario de Alicante Alicante Spain 03010
69 Hospital del Mar Barcelona Spain 08003
70 Hospital Universitari Bellvitge Barcelona Spain 08907
71 Hospital Universitario La Paz Madrid Spain 28046
72 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
73 Hospital Universitario Marques de Valdecilla Santander Spain 39008
74 Gävle sjukhus Gävle Sweden 801 88
75 Södersjukhuset Stockholm Sweden 118 83
76 Karolinska University Hospital in Solna Stockholm Sweden 171 76
77 Västmanlands Sjukhus Västerås Sweden 721 89
78 Universitetssjukhuset Örebro Örebro Sweden 701 85
79 Inselspital - Universitätsspital Bern Bern Switzerland 3010
80 Cardiocentro Ticino Lugano Switzerland 6900
81 Siriraj Hospital Bangkok Thailand 10700
82 Cardiff and Vale University Health Board - University Hospital of Wales (UHW) Cardiff United Kingdom CF14 4XW
83 Royal Infirmary of Edinburgh Edinburgh United Kingdom EH16 4SA
84 Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom EX2 5DW
85 Golden Jubilee National Hospital - NHS Trust Glasgow United Kingdom G81 4HX
86 Royal Free Hospital London United Kingdom NW3 2QG
87 The James Cook University Hospital - South Tees Hospitals NHS Middlesbrough United Kingdom TS4 3BW
88 The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle Upon Tyne United Kingdom NE7 7DN
89 Queen Alexandra Hospital Portsmouth United Kingdom PO6 3LY

Sponsors and Collaborators

  • Medtronic Vascular

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT03344653
Other Study ID Numbers:
  • MDT17054RES007
First Posted:
Nov 17, 2017
Last Update Posted:
Dec 2, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Dec 2, 2020