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Clinical Trials/NCT02412501
NCT02412501
Completed
Not Applicable

A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study

Medtronic Vascular17 sites in 1 country101 target enrollmentStarted: April 6, 2015Last updated:
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Medtronic Vascular
Enrollment
101
Locations
17
Primary Endpoint
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
  • •Must have evidence of ischemic heart disease
  • •Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
  • •Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria

  • •Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • •History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • •History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • •Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • •History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • •Concurrent medical condition with a life expectancy of less than 12 months
  • •Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
  • •Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation

Outcomes

Primary Outcomes

Number of Participants With Target Lesion Failure at 12 Months Post-Procedure

Time Frame: 12 Months

Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.

Secondary Outcomes

  • Number of Participants With Cardiac Death at 12 Months Post Procedure(12 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure(12 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure(12Months)
  • Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure(12 Months)
  • Number of Participants With Cardiac Death at 24 Months Post Procedure(24 Months)
  • Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure(12 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure(24 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure(24 Months)
  • Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure(36 Months)
  • Number of Participants With Cardiac Death at 36 Months Post Procedure(36 Months)
  • Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure(36 Months)
  • Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure(36 Months)
  • Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure(36 Months)
  • Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure(36 Months)

Investigators

Sponsor
Medtronic Vascular
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (17)

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