NCT04110327

An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Micro Medical Solution, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.

Detailed description

Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled: The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.

Conditions

• Peripheral Arterial Disease
• Critical Lower Limb Ischemia

Interventions

Type	Name	Description
DEVICE	MicroStent	Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System

Timeline

• Start date: 2019-10-31
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2019-10-01
• Last updated: 2025-09-22

Locations

10 sites across 5 countries: Austria, Belgium, Germany, Italy, Netherlands