Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.

Key facts

Study ID

NCT00231244

Run by

Cordis US Corp.

People needed

252

Starts

2002-03-01

Expected to finish

2008-11-01

Last updated by the study team

2009-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant female patient minimum 18 years of age
• There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
• Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
• Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;

You may not qualify if…

• There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
• The study target lesion has definite or possible thrombus present by angiographic criteria.

Where it is running

• Scripps Clinic and Research — La Jolla, California, United States

Full record on ClinicalTrials.gov

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