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

NCT00883246 | Completed Results DMC

• 1 other identifier: DEFINITIVE LE
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease; Claudication; Critical Limb Ischemia

Keywords

PAD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Device Success (in All Patients Enrolled)

  Immediately following use of the SilverHawk device

• Procedural Success (in All Patients Enrolled)

  Immediately following use of the SilverHawk and adjunctive devices

• Major Adverse Event Rate (in All Patients Enrolled)

  30 Days

• Major Adverse Event Rate (in All Patients Enrolled)

  One Year

• Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)

  Baseline and 1 Year

Study Arms (1)

Atherectomy

OTHER

All patients enrolled in this single-arm study were treated with directional atherectomy.

Device: SilverHawk & TurboHawk Peripheral Plaque Excision System

Interventions

SilverHawk & TurboHawk Peripheral Plaque Excision System DEVICE

Removal of atherosclerotic plaque from artery walls.

Also known as: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

Atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Related 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.

  PMID: 25147039 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Limitations and Caveats

The study's principal limitations include a lack of randomization and follow-up beyond 12 months.

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Medtronic

michael.p.swierzewski@medtronic.com

763-398-7000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Professor Thomas Zeller

  Herz-Zentrum Bad Krozingen Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 4, 2019
• Results First Posted: October 9, 2015

Record last verified: 2019-05