Clinical Trial News

From Staff Reports

Drugs

Stroke Prevention with Abciximab in Carotid Endarterectomy is a phase I/II interventional study seeking to evaluate the safety of using abciximab during and after open carotid surgery and to determine whether the drug reduces the number of released particles, which may in turn reduce the risk of stroke. The primary outcome of the dose-ranging study will examine the drug's safety to define optimal dose regimen in patients with asymptomatic, less than 75% carotid artery stenosis. The secondary outcome is the incidence of microemboli recorded on transcranial Doppler imaging during carotid endarterectomy with abciximab treatment. The study is sponsored by the University of Rochester (N.Y.) and Eli Lilly \& Co. and expects to enroll 80 patients.

Safety and Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers is a phase I/II interventional study seeking to evaluate the safety and preliminary efficacy of low-dose nicotine gel (ATG002) in patients with chronic diabetic ulcers. The primary outcome is the assessment of ulcer size as determined by weekly ratings, with a secondary outcome of complete wound closure. The multicenter study, which is not yet open for patient recruitment, is being sponsored by Athenagen, and has an expected total enrollment of 48 patients. The projected start is May 2006 with an expected conclusion in December 2006.

Autologous CD34+ Cell Transfer for Severe Intermittent Claudication is a phase I double-blind, randomized study designed to compare the safety and possible efficacy of CD34-positive stem cells with a normal saline placebo for the treatment of patients with blocked arterial flow in the legs leading to pain when walking. The patients will have a 2:1 chance of receiving their autologous bone marrow stem cells versus the placebo. All patients will undergo the stem cell mobilization and apheresis procedure. After all study subjects have been treated and followed for a minimum of 6 months, any placebo-treated patient who continues to have symptoms of severe intermittent claudication will be eligible to crossover and undergo the autologous cell transfer after the 6-month follow-up. The study, which began in April 2006, is being sponsored by the Caritas St. Elizabeth's Medical Center of Boston.

Devices

Follow-Up of Endovascular Aneurysm Treatment--The FEAT Trial is an observational study to investigate the value of magnetic resonance angiography (MRA) in comparison with standard computed tomography angiography (CTA) for monitoring patients who have had endovascular aneurysm repair (EVAR). EVAR requires lifelong follow-up because of the need to monitor the continued exclusion of blood flow from the aneurysm sac. The rationale for the study is long-term patient safety, because MRA uses no ionizing radiation and requires less nephrotoxic contrast agents, compared with CTA. The longitudinal, prospective study began January 2006, with an expected total enrollment of 100 patients and an expected completion date of 2010. It is being sponsored by UMC Utrecht, the Netherlands.

Failed Retrieval of Inferior Vena Cava Filters: Long-Term Outcomes is an observational study to determine the long-term outcomes of patients who undergo temporary IVC filter placement and who subsequently have failed IVC filter retrieval. Primary end points (as measured by CT cavagram) are caval occlusion and stenosis. Chronic or acute deep vein thrombosis will be evaluated with duplex sonography. Secondary end points are adverse events related to the filter as established through physical examination and patient interview. This prospective, single-arm clinical study is sponsored by Bayside Health, Melbourne; it started in August 2005 and expects a total enrollment of 40 patients. The completion date is 2010.