A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemDevice: Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Registration Number
- NCT03344653
- Lead Sponsor
- Medtronic Vascular
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resolute Onyx stent Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 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 Biosensors BioFreedom BA9 Drug Coated Coronary 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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.
Cardiac Death 2 year post- procedure All deaths including cardiac death
Myocardial Infarction 2 year post-procedure All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Stent Thrombosis 2 year post-procedure Stent thrombosis (per Academic Research Consortium (ARC) definition)
Stroke 2 year post-procedure Stroke
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
Bleeding 2 year post-procedure Bleeding per BARC criteria
Revascularization 2 year post-procedure All revascularizations (TLR, TVR and non-TVR)
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.
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.
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
Trial Locations
- Locations (87)
Karolinska University Hospital in Solna
🇸🇪Stockholm, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
Västmanlands Sjukhus
🇸🇪Västerås, Sweden
Inselspital - Universitätsspital Bern
🇨🇭Bern, Switzerland
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Siriraj Hospital
🇹🇭Bangkok, Thailand
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
Royal Free Hospital
🇬🇧London, United Kingdom
Golden Jubilee National Hospital - NHS Trust
🇬🇧Glasgow, 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, United Kingdom
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
🇮🇹Seriate, Bergamo, Italy
Saint Vincent's Hospital (Melbourne)
🇦🇺Fitzroy, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
LKH - Universitätsklinikum Graz
🇦🇹Graz, Austria
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Adelaide Cardiology
🇦🇺Adelaide, South Australia, Australia
Bundaberg Cardiology - Friendly Society Private Hospital
🇦🇺Bundaberg, Queensland, Australia
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck
🇦🇹Innsbruck, Austria
C.H.U. de Charleroi
🇧🇪Charleroi, Belgium
Allgemeines Krankenhaus - Universitätskliniken Wien
🇦🇹Wien, Austria
CHU de Liège - Hôpital du Sart Tilman
🇧🇪Liège, Belgium
Acibadem City Clinic
🇧🇬Sofia, Bulgaria
Queen Elizabeth Hospital (Hong Kong)
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Hôpital Privé Jacques Cartier
🇫🇷Massy, France
San Raffaele Scientific Institute
🇮🇹Milano, Italy
Galway University Hospitals - University Hospital Galway (UHG)
🇮🇪Galway, Ireland
Clinique Axium
🇫🇷Aix-en-Provence, France
Umberto I - Policlinico di Roma
🇮🇹Roma, Italy
Presidio Ospedaliero Ferrarotto Alessi
🇮🇹Catania, Italy
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Paula Stradina Kliniska universitates slimnica
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
🇱🇹Kaunas, Lithuania
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Riga East University Hospital
🇱🇻Riga, Latvia
Hospital Serdang
🇲🇾Kajang, Selangor Darul Ehsan, Malaysia
Sarawak Heart Centre
🇲🇾Kota Kinabalu, Malaysia
Queen Elizabeth II Hospital
🇲🇾Kota Kinabalu, Sabah, Malaysia
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Zuyderland Medisch Centrum Heerlen
🇳🇱Heerlen, Netherlands
HagaZiekenhuis - Locatie Leyweg
🇳🇱Den Haag, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Maastricht Universitair Medisch Centrum (MUMC)
🇳🇱Maastricht, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Isala Zwolle
🇳🇱Zwolle, Netherlands
VieCuri Medisch Centrum voor Noord-Limburg - Locatie Venlo
🇳🇱Venlo, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Wellington Hospital
🇳🇿Newtown, New Zealand
Oslo Universitetssykehus-Ullevål Universitetssykehus
🇳🇴Oslo, Norway
Stavanger Universitetssjukehus - Helse Stavanger HF
🇳🇴Stavanger, Norway
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Miedziowe Centrum Zdrowia
🇵🇱Lubin, Poland
National University Hospital
🇸🇬Singapore, Singapore
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Gävle sjukhus
🇸🇪Gävle, Sweden
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Szpital Kliniczny Przemienienia Panskiego
🇵🇱Poznań, Poland
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
🇸🇰Banska Bystrica, Slovakia
Universitetssjukhuset Örebro
🇸🇪Örebro, Sweden