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

Medtronic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Peripheral Arterial Disease

Treatments: Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733135

FHT-P-07-003

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

Atherectomy with embolic protection

Other group

Description:

All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).

Treatment:

Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device