The Society for Vascular Surgery® is committed to developing and participating in innovative methods to evaluate new treatments for vascular patients with critical limb ischemia (CLI), a significant source of death and disability.

Limb dysfunction, pain, ulceration, and advanced comorbidities render CLI patients extremely vulnerable in considering the safety and effectiveness of new treatments. The evaluation of new devices targeting the CLI population presents major challenges in clinical trial design. The SVS-appointed CLI Performance Goals Work Group aimed to define a set of risk-stratified objective performance goals that may be considered appropriate for the evaluation of new endovascular and minimally invasive therapies for CLI.

Over the course of the 2007-2008 project, the group’s work was informed by a series of collaborative discussions with members of the Federal Drug Administration Peripheral Devices Branch, Division of Cardiovascular Devices, Center for Devices, and Radiological Health.

Premarket assessment of devices for treatment of critical limb ischemia: The role of Objective Performance Criteria and Goals (J Vasc Surg 2009;50:1459-61)

Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia (J Vasc Surg 2009;50:1462-73)

FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia (J Vasc Surg 2009;50:1474-6)

The CLI Performance Goals Work Group Web site (www.criticallimb.org) provides detailed information and results.

Posted June 2010