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

NCT ID: NCT00883246

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atherectomy

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

Group Type: OTHER

SilverHawk & TurboHawk Peripheral Plaque Excision System

Intervention Type: DEVICE

Removal of atherosclerotic plaque from artery walls.

Interventions

SilverHawk & TurboHawk Peripheral Plaque Excision System

Removal of atherosclerotic plaque from artery walls.

Intervention Type: DEVICE

Other Intervention Names

SilverHawk (Atherectomy), TurboHawk (Atherectomy)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

St. Elizabeth's Medical Center, Tuft's University School of Medicine

James McKinsey, MD

Role: PRINCIPAL_INVESTIGATOR

The New York Presbyterian/Columbia University

Professor Thomas Zeller

Role: PRINCIPAL_INVESTIGATOR

Herz-Zentrum Bad Krozingen Germany

References

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.

Reference Type: BACKGROUND

PMID: 25147039 (View on PubMed)

Other Identifiers

DEFINITIVE LE

Identifier Type: -

Identifier Source: org_study_id