Abstract TP17: Magnetically Enhanced Diffusion (MED) for Improved Efficacy of Thrombolytic Therapy in Acute Ischemic Stroke_A Prospective First in Man Clinical Study
BACKGROUND: Preclinical studies have shown that the MED system developed by Pulse Therapeutics, Inc. appears efficient in delivering co-administered agents by affecting the fluid dynamics in targeted occluded arteries. The system is an adjunct to IV rt-PA, and is composed of biologically-safe magnetic particles and a portable magnet system for use in the ED. Preclinical studies support strong efficacy and safety of the MED technology. The primary objective of this feasibility study is to establish the safety (sICH at 24 hours post onset) of the technology when used as an adjunct to IV rt-PA for moderate-to-large (10≤NIHSSS≤24, occlusion confirmed by CTA) ischemic strokes within three hours of acute onset.
METHODS: 10 subjects with moderate-to-large ischemic strokes between ages 18-80 will be enrolled at 2 centers in Australia (Box Hill and John Hunter hospitals). All candidates must possess an intracranial arterial occlusion of the middle cerebral, anterior cerebral, internal carotid, posterior cerebral or distal basilar artery confirmed by CTA or MRA, and must be administered rt-PA within 3 hours of acute onset. Artery selection is input into the MED system and the magnet energized for the entirety of the rt-PA infusion, plus 30min. The primary endpoint is safety as assessed by incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with rt-PA alone. The secondary endpoint is the degree of recanalization (partial and complete) and reperfusion as measured by CTA at 2-4hrs and MRI at 24±6hrs post MED therapy. TIMI Grade Flow of 2 or 3 will be considered responsive to treatment.
CONCLUSIONS: This feasibility trial will attempt to establish the safety (sICH) and recanalization efficacy of the MED technology as an adjunctive therapy to standard-dose IV rt-PA. As of August 2012, Box Hill and John Hunter hospitals have enrolled 2 patients.
- © 2012 by American Heart Association, Inc.