Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Determination of Effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the Treatment of Infrainguinal Vessels/Lower Extremities

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Claudication; Critical Limb Ischemia
• Intervention / Treatment: Device: SilverHawk & TurboHawk Peripheral Plaque Excision System

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atherectomy; All patients enrolled in this single-arm study were treated with directional atherectomy.	Device: SilverHawk & TurboHawk Peripheral Plaque Excision System; Removal of atherosclerotic plaque from artery walls.; Other Names: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)	The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.	One year
Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)	The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success (in All Patients Enrolled)	Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.	Immediately following use of the SilverHawk device
Procedural Success (in All Patients Enrolled)	Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.	Immediately following use of the SilverHawk and adjunctive devices
Major Adverse Event Rate (in All Patients Enrolled)	Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).	30 Days
Major Adverse Event Rate (in All Patients Enrolled)	Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).	One Year
Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)	WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.	Baseline and 1 Year
Improvement in Rutherford Clinical Category (in All Patients Enrolled)	Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.	1 Year
Ankle-Brachial Index (in All Patients Enrolled)	Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.	1 Year
Secondary Patency (in Patients Treated for Claudication RCC 1-3)	Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.	One Year
Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)	The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment	One Year
Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)	Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.	One Year
Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)	Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.	3 months
Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)	Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.	1 year

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Professor Thomas Zeller, Herz-Zentrum Bad Krozingen Germany; Principal Investigator: Lawrence Garcia, MD, St. Elizabeth's Medical Center, Tuft's University School of Medicine; Principal Investigator: James McKinsey, MD, The New York Presbyterian/Columbia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 16, 2009
• First Submitted That Met QC Criteria: April 16, 2009
• First Posted (Estimate): April 17, 2009

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: PAD
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: DEFINITIVE LE