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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atherectomy with embolic protection

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

Group Type OTHER

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

Intervention Type DEVICE

Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No