Status:
COMPLETED
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 modera...
Eligibility Criteria
Inclusion
- Provides written informed consent
- Willing to comply with follow-up evaluations at specified times
- Has leg pain due to peripheral arterial disease
- Disease located within the femoropopliteal artery
- Moderate to severe calcification
Exclusion
- Previously implanted stent(s) or stent graft(s) in target leg
- Life expectancy less than 12 months
- Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00733135
Start Date
October 1 2008
End Date
November 1 2010
Last Update
August 26 2015
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