Status:
COMPLETED
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Arterial Disease
Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00883246
Start Date
April 1 2009
End Date
June 1 2012
Last Update
June 4 2019
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