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First first patient enrolled in PROSPECT II clinical trial
Date:6/13/2014

NEW YORK, NY June 13, 2014 The Cardiovascular Research Foundation (CRF) and Uppsala Clinical Research (UCR) announced today enrollment of the first patient in the PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II) trial. David Erlinge, MD, PhD performed the first procedure at Skane University Hospital in Lund, Sweden.

PROSPECT II is an investigator initiated multicenter, prospective registry study which will assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques which subsequently lead to coronary events. The PROSPECT ABSORB sub study is an investigator initiated multicenter, randomized trial, which for the first time will evaluate the ability of a bioresorbable scaffold to safely increase luminal dimensions of vulnerable plaque.

The PROSPECT II study will enroll 900 patients with acute coronary syndrome (ACS) and will be led by Gregg W. Stone MD, Professor of Medicine at Columbia University Medical Center in New York, and Dr. Erlinge, Professor and Director of the Department of Cardiology, Lund University, Skane University Hospital in Lund, Sweden. Patient enrollment is expected to be completed in approximately one year and the study will be conducted in approximately 16 sites in Scandinavia.

Each patient will be examined with intravascular ultrasound (IVUS) and NIRS in all three coronary arteries. In the PROSPECT ABSORB sub study, 300 patients with a plaque at high risk of causing future coronary events, as shown in the original PROSPECT study (plaque burden ≥70%), will be randomized to treatment with the Absorb Bioresorbable Vascular Scaffold (BVS; Abbott) plus guideline directed medical therapy (GDMT) or GDMT alone, with each patient undergoing angiography and IVUS/NIRS after two years. All 900 patients will be measured at baseline and then followed in the registry for up to 15 years to detect the occurrence
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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