Terumo Commences European TROFI Study of Optical Frequency Domain Imaging

November 24, 2010—Terumo Europe NV (Leuven, Belgium) announced the commencement of patient enrollment in the TROFI study, which is seeking to prove the benefits of thrombus aspiration in treating patients with ST-elevation myocardial infarction (STEMI) using the company's optical frequency domain imaging (OFDI) technology.

The company stated that the Terumo OFDI system is a light-based imaging technology that digitally processes interference signal of backscattered light from the vessel wall and reference light to construct a relevant (~ 20-µm resolution in tissue) intravascular cross-sectional high-resolution image. In the recently completed first-in-man study, OFDI showed superiority in detecting thrombus, tissue prolapse, dissection, and incomplete stent apposition as compared to intravascular ultrasound, with no adverse events related to the device.

According to Terumo, TROFI is a randomized, prospective, multicenter study with the main objective of evaluating whether primary percutaneous coronary intervention (PCI) with Terumo's newest-generation thrombectomy device, Eliminate, as compared to primary PCI without thrombectomy, increases minimal flow area after stenting for treating patients presenting with STEMI as assessed by OFDI. The study is scheduled to enroll 140 patients at five centers in Europe. Patients will be randomly assigned to two arms: patients in the first arm will be treated with the Eliminate thrombus removal device, which showed high deliverability and aspirations capacity; in the second arm, patients will be treated by conventional PCI without the attempt to remove thrombus. All patients will be treated with Terumo's Nobori drug-eluting stent. The Nobori's performance was demonstrated in the NOBORI STEMI study, which enrolled 249 STEMI patients and reported a 4.4% rate of target lesion failure at 12 months, the company stated.



“Enrollment of the first patient in the TROFI study is excellent news, and we are confident that this study will offer some answers that interventional cardiologists were seeking for quite some time,” commented Professor Patrick Serruys, MD, who is the TROFI study's principal investigator. “Minimal flow area as a new endpoint in clinical trials is expected to have predictive values on clinical outcome, whereas the visual images obtained by OFDI that fascinated us in the first-in-man study will help us understand what is going on inside the artery when we perform procedures.”