The ENDEAVOR-I trial enrolled 100 patients at eight centers in Australia and New Zealand. Patients had a reference vessel diameter of 3.0 mm to 3.5 mm, lesion length ¡Ì 15mm, diameter stenosis ©ø 50% and ¡Ì 100% with no other significant lesions in the target vessel. Thirty-day and four-month results from clinical, angiographic and IVUS measurements were presented yesterday. Dr. Meredith said there was 100% lesion, device and procedural success. At 30 days, there was one MACE, a non-Q wave MI with subacute thrombosis necessitating TLR. At four months, there was one additional MACE, a patient complaining of chest pain who required repeat angiography and revascularization of the target lesion for in-stent restenosis. Minimal lumen diameter (MLD) measured 2.84 mm in-stent and 2.52 mm in-segment immediately postop. At four months, MLD measured 2.52 mm in-stent and 2.31 mm in-segment. Late loss measured 0.33 mm in-stent (late loss index = 0.17) and 0.20 mm in-segment (late loss index = 0.11)

In-stent percentage diameter stenosis decreased from 70.3% preop to 5.4% postop. It increased to 14.4% at four months. In-segment percentage diameter stenosis decreased from 70.3% preop to 16.5% postop. It increased to 21.7% at four months. IVUS data showed a 4.5% volume obstruction at four months, a lumen volume of 143 mm and a stent volume of 149 mm. The ENDEAVOR-II trial is currently underway at 96 centers throughout Europe, the Middle East, Asia-pacific and Canada. The primary endpoint for the trial is target-vessel failure at nine months. According to Medtronic, ENDEAVOR-III will begin by the end of this year. Primary endpoint will be late lumen loss assessed by quantitative coronary angiography at eight months.