Antares Coronary Stent System to Facilitate Side Branch Interventions

Not Applicable

• Conditions: Coronary artery disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12609000487213
• Lead Sponsor: TriReme Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

symptomatic or documented myocardial ischemia,
study lesion is a single bifurcation lesion that has not been previously treated,
By angiograpic review the study lesion has a diameter and length appropriate for Antares Stent,

Exclusion Criteria

Acute myocardial infarction, Shock, Stroke, Coagulopathy, Left main coronary lesion, Total occlusion, Diffuse disease, thrombus or severe calcification, Previous Coronary Artery Bypass Graft (CABG) surgery,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bifurcation Treatment Success- assessed by a visual assessment blood flow and stenosis in both the main vessel and side branch.[Measured at the conclusion of the bifurcation procedure]

Secondary Outcome Measures

Name	Time	Method
Major cardiac adverse events including cardiac death, myocardial infarction and Target Lesion Revascularization as determined by clinician observation.[Measured at 1 month, 6 months, and 12 months];Sidebranch Access Success - an evaluation of the ability to access the sidebranch with wire, balloon, and/or stent, to perform sidebranch interventions following Antares stent placement in the main vessel[Determined at the conclusion of the bifurcation procedure]