Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device
- Registration Number
- NCT00733135
- Lead Sponsor
- Medtronic Endovascular
- 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 moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atherectomy with embolic protection SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
- Primary Outcome Measures
Name Time Method Successful Revascularization at the end of the procedure Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory
Major Adverse Event Free Rate 30 Days 30 Days MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
- Secondary Outcome Measures
Name Time Method Preservation of Run-off Distal to the Filter at the end of the procedure Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.
Technical Procedural Success at the end of the procedure Technical Procedural Success was defined as meeting all of the following requirements:
* Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory
* No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)
* No device malfunction causing the procedure to be aborted
* Successful delivery and placement of the SpiderFX™ embolic protection devicePresence of Debris in Deployed SpiderFx™ Embolic Protection Device at the end of the procedure Presence of debris in deployed SpiderFx™ embolic protection device
Residual Diameter Stenosis at the end of the procedure This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.