RecruitingACTRN12609000724279

Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions

A Prospective, Multicentre Trial to assess the safety & effectiveness of an Everolimus-Eluting Coronary Stent System (PROMUS Element) for the Treatment of a Single De Novo Coronary Artery Long Lesion (24 - 34mm in length)


Sponsor

Boston Scientific Pty Ltd

Enrollment

102 participants

Start Date

Aug 21, 2009

Study Type

Interventional

Conditions

Summary

The PROMUS Element Long Lesion clinical trial –PLATINUM LL, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with a lesion that is 24-34mm in length. Treatment will be in participants with a single de novo (new or untreated) atherosclerotic coronary artery lesion. A separate coronary artery (de novo) narrowing is able to be treated with a commercial treatment (eg: stent such as PROMUS, balloon angioplasty, excluding brachytherapy) during the initial procedure. Up to 35 sites enrolling up to 102 patients. Follow up at 30 days, 6 and 12 months after intervention.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a heart stent — a small mesh tube placed inside a narrowed heart artery — called the PROMUS Element Everolimus-Eluting Coronary Stent, in patients with longer blockages (24 to 34 mm) in their heart arteries. Heart artery disease (coronary artery disease) can cause chest pain and heart attacks. A stent is placed during a procedure called PCI (percutaneous coronary intervention) to hold the artery open. This drug-eluting stent releases a medication called everolimus to prevent the artery from re-narrowing. The PLATINUM LL trial will follow patients for 12 months to assess safety and effectiveness. You may be eligible if: - You are 18 years of age or older - You have documented stable or unstable angina or silent ischaemia - You have a new (untreated) narrowing in a native coronary artery that is 24–34 mm long - Your heart pumping function is above 30% - You would be a candidate for bypass surgery if needed You may NOT be eligible if: - You have had a heart attack within 72 hours before the procedure with elevated cardiac enzymes - The target artery was treated with any intervention in the past 12 months - You are on chronic anticoagulation therapy - You are pregnant, nursing, or planning pregnancy within 12 months Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. One stent will be permanently implanted in the patient via use of a catheter inserted int

The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. One stent will be permanently implanted in the patient via use of a catheter inserted into the vasculature. The drug dosage depends on the size of the stent and varies from 57 micrograms (2.25x12mm stent) to 242 micrograms (4.0x38mm stent) and this drug is gradually released into the surrounding arterial tissue for approximately 3 months following stent implantation. Stent size is selected by the investigator based on vessel diameter and length. Typically stent diameter is selected to be slightly larger than the vessel diameter (ie a 3.0mm stent would be used to treat a 2.8mm vessel). Typically stent length is selected so that the stent is 2-4mm longer than the lesion length (ie a 28mm stent would be used to treat a 22mm lesion)


Locations(3)

New Zealand

Japan

United States of America

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ACTRN12609000724279