NEW YORK (Reuters Health) - Mechanical embolectomy with the Merci Retriever, an endovascular device designed for the cerebral vasculature, is a safe and potentially effective treatment for cerebral ischemia, the findings of a phase I trial indicate.
The study results, which appear in the December issue of Stroke, stem from a study of 28 patients who participated in the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 trial.
To be eligible for the study, the patients needed to have a National Institutes of Health Stroke Scale (NIHSS) score of at least 10. In addition, blockage of a major cerebral artery needed to be seen on angiogram, embolectomy had to be performed within 8 hours of symptom onset, and the patient had to have no contraindications to thrombolysis.
The median NIHSS score was 22 and the median time from symptom onset to treatment completion was 6 hours and 15 minutes, lead author Dr. Y. Pierre Gobin, from New York Presbyterian Hospital, and colleagues note.
Successful recanalization was achieved in 18 patients, including 12 recanalized with mechanical embolectomy alone and 6 who also required intraarterial thrombolysis.
Although 12 intracranial hemorrhages occurred, none were symptomatic or clinically relevant. In one patient, the tip of the Merci catheter detached from the device, but it was retrieved without consequence using another catheter.
At 1-month follow-up, 9 of the 8 recanalized patients and none of the 10 non-recanalized patients showed significant functional recovery.
“Although the number of patients in this phase I study is small, these results suggest that mechanical embolectomy performed within 8 hours from symptom onset in moderate and severe stroke may benefit half the cohort of successfully recanalized patients with minimal risk of symptomatic hemorrhage or device-related complications,” the authors state.
The study was funded by Mountain View, California-based Concentric Medical, Inc, which is marketing the Merci Retrieval System.
Source: Stroke 2004;35:2848-2854. [ Google search on this article ]
MeSH Headings:Clinical Trials: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Medicine: Investigative Techniques: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Epidemiologic Study Characteristics: Clinical Trials, Phase I: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
