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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883246
• Other study ID #: DEFINITIVE LE
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2019
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Claudication
• Critical Limb Ischemia
• Intermittent Claudication
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• SilverHawk & TurboHawk Peripheral Plaque Excision System
Removal of atherosclerotic plaque from artery walls.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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