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

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

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