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

2019-10-07 08:56:57 | BioPortfolio

Summary

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

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

Conditions

Peripheral Arterial Disease

Intervention

MicroStent

Location

OLV Hospital
Aalst
Belgium

Status

Not yet recruiting

Source

Micro Medical Solution, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-07T08:56:57-0400

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