CompletedPhase 2/3

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

133 participantsStarted 2008-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Successful Revascularization

Timeframe: at the end of the procedure

Major Adverse Event Free Rate 30 Days

Timeframe: 30 Days

Trial details

NCT IDNCT00733135

SponsorMedtronic Endovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2014-06-05

View on ClinicalTrials.gov More Peripheral Arterial Disease trials