FDA perspective on clinical trial design for femoropopliteal stent correction of peripheral vascular insufficiency cardiovascular devices

Catheterization and Cardiovascular Interventions

Volumn 69, Issue 6, 2007, Pages 920-921

  Goode, Jennifer ^a   Sapirstein, Wolf ^a   Zuckerman, Bram ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL STUDY; FEMORAL ARTERY; FEMOROPOPLITEAL STENT; FOOD AND DRUG ADMINISTRATION; HUMAN; MARKETING; NOTE; PERFORMANCE; PERIPHERAL VASCULAR DISEASE; POPLITEAL ARTERY; SAFETY; STENT;

CLINICAL TRIALS; FEMORAL ARTERY; GUIDELINES; HUMANS; INTERDISCIPLINARY COMMUNICATION; INTERINSTITUTIONAL RELATIONS; PERIPHERAL VASCULAR DISEASES; POPLITEAL ARTERY; RESEARCH DESIGN; STENTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VASCULAR SURGICAL PROCEDURES;

EID: 34249903911     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21209     Document Type: Note

References (4)

1. Rocha-Singh KJ, Jaff MR, Crabtree TR, et al. Performance Goals and Endpoint Assessments for Clinical Trials of Femoropopliteal Bare Nitinol Stents in Patients with Symptomatic Peripheral Arterial Disease. Catheter Cardiovasc Interv 2007;69:910-919.
2. Food Drug and Cosmetic Act Amendment. Federal Register 43FR 32988. Washington, DC. Govt. Printing Office. 1978.
3. Food Drug and Cosmetic Act Amendment. Federal Register 21U.S.C. 396. Section 906, Vol. 63. 1998. p 64617.
4. Least Burdensome Provisions of the FDA Modernization Act of 1997. Available at http://www.fda.gov/cdrh/ode/guidance/1332.pdf.