Standardized Objective Performance Criteria and Control Datasets

In previous issues of Endovascular Today, we have described some ongoing initiatives in the Peripheral Vascular Devices Branch intended to optimize our regulation of peripheral vascular devices. Several of these initiatives involve the establishment of standardized objective performance criteria (OPC) and control datasets for various peripheral devices, including iliac stents and endovascular grafts. Level one evidence from a controlled clinical trial may be optimal for establishing the standard of care for a given patient population; however, this level of evidence is not always necessary to demonstrate that a particular medical device offers a reasonable treatment option for patients. Alternative study designs include single-arm comparisons to OPCs or control datasets. When using OPCs, a new device must be demonstrated to be no worse than the specified numbers in the OPCs, with a prespecified margin of error. In contrast, the standardized control dataset is used in place of prospectively collected control data, generally with the expectation that there would be an improvement in the new/investigational endovascular treatment as compared to the control dataset.