RESOLUTE ONYX China Single Arm Study

Launched by MEDTRONIC VASCULAR · Mar 19, 2018

Keywords

ClinConnect Summary

The RESOLUTE ONYX China Single Arm Study is a clinical trial that is looking at the safety and effectiveness of a special heart stent called the Medtronic Resolute Onyx™. This stent is designed to help open blocked arteries in patients who have ischemic heart disease or other related heart conditions. The study is specifically for people in China who need treatment for new blockages in their heart arteries and are suitable candidates for a procedure called percutaneous coronary intervention (PCI), which helps clear these blockages.

To participate in this study, individuals must be between the ages of 65 and 74 and meet certain health criteria, such as needing treatment for up to three specific blockages in two different blood vessels. They should not have any known allergies to certain medications or materials used in the stent, nor have had recent heart procedures that could complicate the study. If eligible, participants can expect to receive the stent as part of their treatment, and their progress will be closely monitored to ensure their safety and the stent’s effectiveness. This trial is currently active, but it is not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
• • The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm
• Key Exclusion Criteria:
• • Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
• • PCI of the target vessel within 9 months prior to the procedure
• • Active bleeding
• • Subjects with a life expectancy of less than 12 months
• • Participation in another clinical study
• • Pregnant, or lactating women