Endovascular revascularization of intracranial vessels is technically feasible and may be performed successfully. However, periprocedural complication and fatality rates in neurologically unstable patients are high. The results suggest that patient selection, procedure timing, and periprocedural medical management are critical factors to reduce periprocedural morbidity and mortality.
Our results lend further support to the safety and efficacy of DPTE in the management of hypervascular neoplasms of the head and neck. With our increasing experience, this technique is evolving into a primary therapeutic modality for optimal tumor devascularization.
Background—
Obtaining viable informed consent from stroke patients for participation in clinical trials of acute stroke therapies is often problematic because of patients’ neurological deficits. Furthermore, obtaining permission from surrogates is often not possible or not legally permissible.
Summary of Review—
In 1996 the Food and Drug Administration and Department of Health and Human Services published regulations that allow investigators to conduct emergency research without patient consent under a narrowly defined set of circumstances. We review requirements of these regulations, paying particular attention to how they may be applied in a clinical trial of an acute stroke therapy.
Conclusions—
Acute stroke researchers should consider conducting clinical trials with an exception from the informed consent requirement permitted by this law.
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