NCT04282161

Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Axys EX device	Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-08-01
• Completion: 2024-02-01
• First posted: 2020-02-24
• Last updated: 2021-04-05

Regulatory

• FDA-regulated device study