N/A
Completed N=799
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
Peripheral arterial disease · Claudication · Critical Limb Ischemia
Source: ClinicalTrials.gov NCT00883246 ↗
Enrolled (actual)
799
Serious AEs
51.3%
Results posted
Oct 2015
Primary outcomePrimary: Primary Patency Rate (in Patients Treated for Claudication RCC 1-3) — 81.6 percentage of lesions by Kaplan Meier
Summary
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency Rate (in Patients Treated for Claudication RCC 1-3) |
81.6 | — |
| PRIMARY Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6) |
95.1 | — |
| SECONDARY Device Success (in All Patients Enrolled) |
70.5 | — |
| SECONDARY Procedural Success (in All Patients Enrolled) |
84.0 | — |
| SECONDARY Major Adverse Event Rate (in All Patients Enrolled) |
20.9 | — |
| SECONDARY Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3) |
19.9; 49.5; 20.3; 39.4; 32.0; 53.9 | — |
| SECONDARY Improvement in Rutherford Clinical Category (in All Patients Enrolled) |
82.3 | — |
| SECONDARY Ankle-Brachial Index (in All Patients Enrolled) |
76 | — |
| SECONDARY Secondary Patency (in Patients Treated for Claudication RCC 1-3) |
93.5 | — |
| SECONDARY Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6) |
74.1 | — |
| SECONDARY Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3) |
99.6 | — |
| SECONDARY Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6) |
61.2 | — |
| SECONDARY Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3) |
77.5 | — |
Eligibility Criteria
Inclusion Criteria
- Has a Rutherford Clinical Category Score of 1 - 6.
- Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
- Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
- Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
- Each discrete target lesion's length is ≤ 20 cm.
- Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm.
Exclusion Criteria
- Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
- Has had a previous peripheral bypass affecting the target limb.
- Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
- Has presence of severe calcification in target lesion(s).
- Has in-stent restenosis of the target lesion.
- Has an aneurysmal target vessel.
- Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel.
- Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment.
- Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s).
- Has had a previous amputation above the metatarsal line on the target limb.
Data sourced from ClinicalTrials.gov (NCT00883246). 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. Informational only — not medical advice.