Clinical trial NCT00883246: Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
Official title: Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication
Critical Limb Ischemia
Keywords: PAD
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)
timeFrame: One year
measure: Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)
timeFrame: One Year
Secondary outcomes:
measure: Device Success (in All Patients Enrolled)
timeFrame: Immediately following use of the SilverHawk device
measure: Procedural Success (in All Patients Enrolled)
timeFrame: Immediately following use of the SilverHawk and adjunctive devices
measure: Major Adverse Event Rate (in All Patients Enrolled)
timeFrame: 30 Days
measure: Major Adverse Event Rate (in All Patients Enrolled)
timeFrame: One Year
measure: Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)
timeFrame: Baseline and 1 Year
measure: Improvement in Rutherford Clinical Category (in All Patients Enrolled)
timeFrame: 1 Year
measure: Ankle-Brachial Index (in All Patients Enrolled)
timeFrame: 1 Year
measure: Secondary Patency (in Patients Treated for Claudication RCC 1-3)
timeFrame: One Year
measure: Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)
timeFrame: One Year
measure: Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)
timeFrame: One Year
measure: Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)
timeFrame: 3 months
measure: Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: St. Elizabeth's Medical Center, Tuft's University School of Medicine
name: Lawrence Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The New York Presbyterian/Columbia University
name: James McKinsey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herz-Zentrum Bad Krozingen Germany
name: Professor Thomas Zeller
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006.