NCT00733135

Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device	Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-08-12
• Last updated: 2015-08-26
• Results posted: 2014-07-04