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Do I have to consent the patient for RELAX (REvascularization of Leg Arteries with the Xpert™ stent) prior to treatment?

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Do I have to consent the patient for RELAX (REvascularization of Leg Arteries with the Xpert™ stent) prior to treatment?

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No. Patients may be consented within 30 days of treatment. However, you must consent all patients that you treat (consecutive enrollment). In other words, if you use the Xpert™ stent BTK for CLI, you must consent the patient and enroll in the RELAX (REvascularization of Leg Arteries with the Xpert™ stent) registry within 30 days. There are no exclusion criteria for the registry. Data will be collected at 30 days, 6 months and one year via the secure RELAX (REvascularization of Leg Arteries with the Xpert™ stent) web site.

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