Completed NA INTERVENTIONAL 1-arm NCT00883246

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

Sponsor: Medtronic Endovascular

Conditions Claudication Critical Limb Ischemia Peripheral Arterial Disease

Interventions SilverHawk & TurboHawk Peripheral Plaque Excision System

Updated 11 times since 2017 Last updated: May 23, 2019 Started: Apr 30, 2009 Primary completion: Jun 30, 2012 Completion: Jun 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Claudication and Critical Limb Ischemia, this trial is completed. The trial is conducted by Medtronic Endovascular and has accumulated 11 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

11 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Jan 2023 — Jul 2024 [monthly]

Completed NA
Dec 2022 — Jan 2023 [monthly]

Completed NA
Dec 2021 — Dec 2022 [monthly]

Completed NA

▶ Show 6 earlier versions

Jan 2021 — Dec 2021 [monthly]

Completed NA
Sep 2020 — Jan 2021 [monthly]

Completed NA
Jul 2019 — Sep 2020 [monthly]

Completed NA

Phase: PHASE4 → NA
Jun 2018 — Jul 2019 [monthly]

Completed PHASE4
Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Apr 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Medtronic Endovascular

Data source: Medtronic Endovascular

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.