e-Healing (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth), Genous Bio-engineered R stent, Post Marketing Registry.

Phase 4

Recruiting

• Conditions: Coronary artery disease; Respiratory - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12605000801617
• Lead Sponsor: OrbusNeich Medical Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

A group of selected patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to de novo and/or restenotic coronary artery lesions. The Genous stent is suitable for treatment of atherosclerotic or restenotic lesions with a length less than the nominal stent length in coronary arteries having reference vessel diameters of the stent expanded diameter following primary inflation.

Exclusion Criteria

Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is Target Vessel Failure (TVF)[At 12 months]

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes include: procedure success, angiographic success (visual estimate), MACE.[At 30 day, 6 and 12 months.];Device related SAES until 12 months and angiographic stent thrombosis.[]