title: FDA perspective on objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.
abstract: The article by Conte et al.(1) on behalf of the Society for Vascular Surgery (SVS) in this issue of the Journal of Vascular Surgery provides guidelines for improving the consistency and interpretability of clinical trials intended to evaluate treatment options for patients with critical limb ischemia (CLI). This article identifies a number of key challenges with conducting and comparing CLI trials, including the wide spectrum of clinical presentations that CLI encompasses, the use of disparate eligibility criteria and endpoint measurements, and logistical and economic considerations that can limit study initiation and completion. The authors propose definitions for a number of performance goals derived from historical surgical literature as a means of reducing the negative impact of these factors. The current editorial reviews aspects of this proposal from the perspective of the authors in terms of their understanding of the statutory obligations of the U.S. Food and Drug Administration (FDA) to regulate the marketing of cardiovascular devices based on valid scientific evidence.
authors.affiliation: Division of Cardiovascular Devices, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Silver Spring, Md 20993, USA. allison.kumar@fda.hhs.gov
authors.forename: Allison
authors.initials: A
authors.lastname: Kumar
authors.forename: Steven S
authors.initials: SS
authors.lastname: Brooks
authors.forename: Kenneth
authors.initials: K
authors.lastname: Cavanaugh
authors.forename: Bram
authors.initials: B
authors.lastname: Zuckerman
mesh_terms: D026683:Advisory Committees; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D018849:Controlled Clinical Trials as Topic; D016638:Critical Illness; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D019317:Evidence-Based Medicine; D005121:Extremities / Q000098:blood supply*; D006801:Humans; D007511:Ischemia / Q000601:surgery / Q000628:therapy*; D017410:Practice Guidelines as Topic; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012955:Societies, Medical; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*