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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 250 subjects in three cohorts will be enrolled: Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #1: Claudication; Rutherford ≤3 Up to 100 subjects or 1-year recruitment, whichever comes first in Cohort #2: Critical Limb Ischemia; Rutherford 4-5 Up to 50 subjects or 1-year recruitment, whichever comes first in Cohort #3: Critical Limb Ischemia w/major tissue loss; Rutherford 6 Sites may follow routine follow up intervals per their standard of care, with data regarding clinical assessments regarding limb status being collected. Data from these visits that do not fall in the expected visit windows will be captured in the study database as unscheduled visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04110327
Study type Observational [Patient Registry]
Source Micro Medical Solution, Inc.
Contact Esmeralda Sanjust di Teulada
Phone (415) 370-6757
Email esmeraldas@micromedicalsolutions.net
Status Recruiting
Phase
Start date October 31, 2019
Completion date January 31, 2024
View Details
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