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Patient Enrollment for the Valentines Trial

Date: 2009/10/22

Patient Enrollment for the Valentines Trial to Continue Throughout Cardiovascular Research Technologies (CRT) 2010

Washington, DC, and Bonn, Germany, October 22, 2009

Washington, DC, and Bonn, Germany, October 22, 2009 ― A new approach to real-world registries will be performed during Cardiovascular Research Technologies (CRT) 2010 to be held February 21-23, 2010 in Washington DC. Enrollment for the Valentines Trial will begin February 14, 2010, and will last until February 23, 2010.

The first of its kind, the Valentines trial is a multicenter, open-label, one-week registry of up to 300 patients recruited from up to 100 centers around the globe who present with in-stent restenosis (ISR) of a previously placed stent. Results will be presented at CRT 2011. Three principal investigators will chair the trial: Dr. Giuseppe Sangiorgi (Modena, Italy), Prof. Dr. Sigmund Silber (Munich, Germany), and Dr. Pieter R. Stella (Utrecht, Netherlands).

Eurocor GmbH (Bonn, Germany) will provide the DIOR™ drug-eluting balloon for use in the trial and will manage both the trial and its investigators via its own organization and the international distributor network. All data for analysis will be collected via an electronic data capture system and analyzed within the Cardiovascular Research Institute Data Coordinating Center of the Washington Hospital Center.

“Currently we even cannot predict the number of patients which will be enrolled in this trial, and we can only tell after the trial is closed at the end of 23rd of February. We hope to build one of the largest databases for treatment of ISR world-wide within a very short time,” said Dr. Rembert Pogge von Strandmann, Director, Clinical Studies, for Eurocor.

“This is a brilliant and fresh approach to test globally a device in a real-world environment and to complete a study within a week of enrolment”, said Prof. Ron Waksman, MD, of the Cardiovascular Research Institute and CRT course chairman.

“We encourage clinical investigators who wish to qualify for this trial to contact us via the CRT Website (www.crtonline.org) or via email at valentinestrial@eurocor.de.” commented the principal investigators during a recent investigators meeting.

Further details please follow: http://www.crtonline.org/pr.aspx?PAGE_ID=6963

For further information please visit: http://www.valentines-trial.com.