NCT01378260

Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 323 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses; Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management. Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.

Conditions

• Peripheral Arterial Disease
• Claudication

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-09-01
• Completion: 2015-08-01
• First posted: 2011-06-22
• Last updated: 2017-05-18

Locations

12 sites across 1 country: United States