Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear

Not Applicable

• Conditions: Ischemic heart disease

• Registration Number: JPRN-UMIN000034936
• Lead Sponsor: Medtronic Japan Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

1) Pregnant and breastfeeding women 2) Subjects requiring a planned PCI procedure after one month of index procedure 3) Procedure planned to require non-study stents, stand-alone POBA, or stand-alone atherectomy 4) Active bleeding at the time of inclusion 5) Cardiogenic shock 6) Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure 7) Subject not expected to comply with long-term single antiplatelet therapy 8) A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g., 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. 9) PCI during the previous 6 months for a lesion other than the target lesion of the index procedure 10) Participation in another clinical study within 12 months after index procedure 11) Subjects with life expectancy of less than 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of cardiac death and myocardial infarction at one year for a one-month clear population [time frame: one month to one year]