Clinical trial NCT03647475: 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)
Official title: Onyx ONE Clear: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, single arm trial enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
timeFrame: One Month to one year
Secondary outcomes:
measure: Number of Participants With Target Lesion Failure
timeFrame: One Month to One Year
measure: Number of Participants With Procedure Success
timeFrame: Procedure to hospital discharge, an average of 1.3 days
measure: All Participants Deaths Including Cardiac Death
timeFrame: One Month to One Year
measure: Number of Patients With Major Cardiac Event
timeFrame: One Month to One Year
measure: Number of Patients With Myocardial Infarction
timeFrame: One Month to One Year
measure: Number of Patients With Target Vessel Failure
timeFrame: One Month to One Year
measure: Number of Patients With Revascularization
timeFrame: One Month to One Year
measure: Number of Patients With Stent Thrombosis
timeFrame: One Month to One Year
measure: Number of Patients With Bleeding
timeFrame: One Month to One Year
measure: Number of Patients With Stroke
timeFrame: One Month to One Year
measure: Lesion Success
timeFrame: End of Procedure, an average of 42 minutes
measure: Device Success
timeFrame: End of Procedure an average of 42 minutes
Other outcomes:
Locations:
city: East Syracuse
country: United States
facility: Saint Joseph's Hospital Health Center
state: New York
city: New York
country: United States
facility: New York- Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: Piedmont Atlanta Hospital, Atlanta, GA
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY
name: Ajay Kirtane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW; Onyx ONE US/Japan Investigators. One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients. Circ Cardiovasc Interv. 2020 Nov;13(11):e009565. doi: 10.1161/CIRCINTERVENTIONS.120.009565. Epub 2020 Nov 10.