Completed NA INTERVENTIONAL 3-arm NCT01366482

Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease (DEFINITIVE AR)

Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment

Sponsor: MEDRAD, Inc.

Conditions Claudication Peripheral Arterial Disease

Interventions Cotavance Drug-Eluting Balloon TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Updated 6 times since 2017 Last updated: May 24, 2019 Started: Jul 31, 2011 Primary completion: May 31, 2014 Completion: May 31, 2014

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

This NA trial investigates Claudication and Peripheral Arterial Disease and is currently completed. MEDRAD, Inc. leads this study, which shows 6 recorded versions since 2011 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Jan 2021 — Jul 2024 [monthly]

Completed NA
Jun 2019 — Jan 2021 [monthly]

Completed NA

Phase: PHASE1_PHASE2 → NA
Jun 2018 — Jun 2019 [monthly]

Completed PHASE1_PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE1_PHASE2

First recorded

Jul 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

MEDRAD, Inc.
Medtronic Endovascular

Data source: Medtronic Endovascular

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

Study Locations

• Bonheiden, Belgium