Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-02-07 @ 3:31 AM
Study NCT ID:
NCT04282161
Status:
WITHDRAWN
Last Update Posted:
2021-04-05
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
Sponsor:
Medtronic Endovascular
Organization:
Study Overview
Official Title:
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System for the Treatment of Peripheral Arterial Disease in the Vasculature of the Lower Limbs
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Axys ACHIEVE
Brief Summary:
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: