Aug 23 2011
itm FlowMedical GmbH announced the start of OPEN-188 (Outcome Post Endovascular Brachytherapy for Neointimal Hyperplasia -Rhenium-188) clinical trial. It will compare itm Rhenium-PTA®, a therapy for the prevention of restenosis in peripheral vessels, to a regular PTA (balloon dilatation), the standard therapy for the treatment of PAOD (peripheral artery occlusive disease). The first successful treatments in this clinical trial took place in May 2011. The purpose of this study is to investigate the effectiveness, side effects and cost effectiveness of endovascular brachytherapy with Rhenium-188.
The clinical trial is being conducted under the leadership of Principal Investigator, Dr. med. Giesbert Leissner, a specialist in diagnostic radiology and surgery at Augsburg Hospital. Ten highly specialized clinical centres in Germany are participating in this prospective, randomized and economic evaluation clinical study. OPEN-188 will include 140 patients with PAOD - 70 patients will be treated with a regular PTA only (placebo group) and 70 patients will receive an itm Rhenium-PTA® (verum group). Clinical follow-ups will take place after six and twelve months. It is expected that the results of the latter will be available mid-2013.
Restenosis and in-stent restenosis, the reclosing of arteries after surgery interventions, continue to plague vascular intervention techniques. Within minutes after a balloon reopens a clogged vessel, the cells of the treated vessel wall start growing. itm Rhenium-PTA® decelerates the excessive cell growth and the vessel remains open. The liquid isotope, Rhenium-188, emits a tightly focused beta radiation that allows precise treatment of the target vessel wall (media-adventitia). After a conventional balloon dilatation, a special PTA catheter filled with Rhenium-188 is placed at the previously treated area. Through the thin texture of the balloon, the isoptope can effectively irradiate the affected area on the spot.
Due to itm FlowMedical's innovative mobile application device, radiation protection for patients and hospital personnel is excellent. Rhenium-188 has a short half life of 17 hours, which means that after three weeks it is an inert solution that can be discarded easily. Since itm Rhenium-PTA® received the CE mark in 2008, 15 specialized German hospitals have been routinely applying the therapy. Even though the therapy is suitable for a broad range of various peripheral indications, its main focus is the treatment of particularly serious cases of PAOD (i.e. Fontaine stage III, daily rest pain and Fontaine IV, focal tissue necrosis) in the upper leg and knee. The portfolio will be extended to the treatment of the lower leg soon.
The medical effectiveness of endovascular brachytherapy has been clearly proven in many clinical studies. According to Dr. med. Giesbert Leissner, "itm Rhenium-PTA® is a development of endovascular brachytherapy that solves former shortcomings; such as, a too low irradiation dose, an inhomogeneous irradiation of the vessel wall and an inadequate radiation protection for patients and clinical personnel."
Source: FlowMedical
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