INNOVATION trial: First patients enrolled in study of new stent graft system to treat AAA

Published date : 01 June 2010
Article date : 01 June 2010

The first patients have been enrolled in the INNOVATION trial, which will assess the safety and performance of a new stent graft system, the Incraft (Cordis), to treat abdominal aortic aneurysm (AAA).

The Incraft’s delivery system features a low-profile that is made possible by using an integrated sheath of braided construction. The outer diameter of the integrated delivery system, which includes the device and sheath is 14F, whereas currently available endovascular aneurysm repair (EVAR) devices have system profiles ranging from 18 to 24 F.

Cordis Incraft

The INNOVATION trial is a multi-centre, open-label, prospective, non-randomised study assessing the Incraft system in subjects with AAA. It will enrol up to 25 patients in three sites throughout Germany.

According to trial investigator Professor Giovanni Torsello, Chief of Vascular Surgery at St Franziskus Hospital, Muenster, “I am pleased to be a part of the INNOVATION trial. The ability to customise the Incraft system during the procedure is a very helpful feature for clinicians.”

The initial procedures using the system were performed by principal investigator Professor Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology at Park-Krankenhaus Hospital in Leipzig. Scheinert commented, “We have been excluding a significant portion of our AAA patients, especially women, from EVAR because current stent grafts have large and bulky delivery systems, making device introduction impossible for small or diseased access vessels. The ultra-low profile delivery system of Incraft will make EVAR a possible treatment alternative for a wider range of patients.”

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