NCT00883246

Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.

Conditions

• Peripheral Arterial Disease
• Claudication
• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	SilverHawk & TurboHawk Peripheral Plaque Excision System	Removal of atherosclerotic plaque from artery walls.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-04-17
• Last updated: 2019-06-04
• Results posted: 2015-10-09