Phase 3
N=133
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00733135 ↗Enrolled (actual)
133
Serious AEs
19.6%
Results posted
Jul 2014
Primary outcome: Primary: Successful Revascularization — 92.0 percentage of lesions — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Revascularization |
92.0 | <0.05 sig |
| PRIMARY Major Adverse Event Free Rate 30 Days |
93.1 | — |
| SECONDARY Technical Procedural Success |
88.6 | — |
| SECONDARY Residual Diameter Stenosis |
64.1 | — |
| SECONDARY Presence of Debris in Deployed SpiderFx™ Embolic Protection Device |
88.4 | — |
| SECONDARY Preservation of Run-off Distal to the Filter |
98.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00733135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.