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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• 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

Study Timeline

• Study First Submitted: 2017-10-20
• Study Start: 2017-11-02
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Primary Completion: 2018-09-27
• Study Completion: 2020-10-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Royal North Shore Hospital; 🇦🇺 Saint Leonards, New South Wales, 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

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Adelaide Cardiology; 🇦🇺 Adelaide, South Australia, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Saint Vincent's Hospital (Melbourne); 🇦🇺 Fitzroy, Victoria, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

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