The trial is a post-market registry, prospective, multi-center study taking place in Europe, Asia and other areas outside of the US. This registry is designed to evaluate real-world use and clinical performance of the Medtronic Endeavor drug-eluting coronary stent system in patients with coronary artery disease. The stent received approval from the European Commission in July.
The primary endpoint for the study is major adverse cardiac events (MACE) at one year. Secondary endpoints include MACE at 30 days and six months, stent thrombosis rate at 24 hours, from 2-30 days and at 30 days or longer, and procedural, clinical and lesion success rates.
The Endeavor drug-eluting stent is made of a cobalt alloy and has a unique modular architecture designed to enhance deliverability over standard bare metal stents. In addition to the proprietary drug compound ABT-578, the Endeavor stent is coated with phosphorylcholine (PC), a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane.
Scott Ward, president of Medtronic Vascular said: “This type of follow-up will give physicians an accurate ‘real-world’ assessment of the patient population they see on a daily basis.”