Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT04110327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Sponsor:
Micro Medical Solution, Inc.
Organization:
Study Overview
Official Title:
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEAL
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: