A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

Not Applicable

Completed

Conditions: Coronary Artery Disease

Registration Number: NCT03647475

Lead Sponsor: Medtronic Vascular

Brief Summary: The purpose of this trial 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: 752

Inclusion Criteria

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:

Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
Any prior documented intracerebral bleed
Any documented stroke in the last 12 months
Hospital admission for bleeding during the prior 12 months
Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
Planned surgery that would require interruption of DAPT (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
Expected non-compliance for at least 6 months DAPT for other medical reasons

Exclusion Criteria

Pregnant and breastfeeding women
Subjects requiring a planned PCI procedure after 1 month of index procedure
Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
Active bleeding at the time of inclusion
Cardiogenic shock
Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
Subject not expected to comply with long-term single antiplatelet therapy
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: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction	One Month to one year	Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Myocardial Infarction	One Month to One Year	All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
Lesion Success	End of Procedure, an average of 42 minutes	The attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
All Participants Deaths Including Cardiac Death	One Month to One Year	All participants deaths including cardiac death
Number of Patients With Major Cardiac Event	One Month to One Year	Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
Number of Patients With Target Vessel Failure	One Month to One Year	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.
Number of Patients With Revascularization	One Month to One Year	All revascularizations (TLR, TVR and non-TVR)
Number of Patients With Stent Thrombosis	One Month to One Year	Stent thrombosis (per Academic Research Consortium (ARC) definition)
Number of Patients With Bleeding	One Month to One Year	Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: * BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories * BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories * All BARC- This included all bleeding events BARC 1 through BARC 5
Number of Patients With Stroke	One Month to One Year	Stroke
Number of Participants With Target Lesion Failure	One Month to One Year	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 method
Number of Participants With Procedure Success	Procedure to hospital discharge, an average of 1.3 days	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	End of Procedure an average of 42 minutes	Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

Trial Locations

Locations (4): New York- Presbyterian Hospital/Columbia University Medical Center
🇺🇸
New York, New York, United States
Saint Joseph's Hospital Health Center
🇺🇸
East Syracuse, New York, United States
AnMed Health Medical Center
🇺🇸
Anderson, South Carolina, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States