Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 133
- Primary Endpoint
- Successful Revascularization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Atherectomy with embolic protection
All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).
Intervention: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device (Device)
Outcomes
Primary Outcomes
Successful Revascularization
Time Frame: 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
Time Frame: 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 Outcomes
- Preservation of Run-off Distal to the Filter(at the end of the procedure)
- Technical Procedural Success(at the end of the procedure)
- Presence of Debris in Deployed SpiderFx™ Embolic Protection Device(at the end of the procedure)
- Residual Diameter Stenosis(at the end of the procedure)