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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2028-12-31

Brief Summary

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

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Detailed Description

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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

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Peripheral Arterial Disease Critical Lower Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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MicroStent

Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use
2. For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment
3. Subject's age is ≥ 18 years.
4. Subject must be willing to sign a patient informed consent form.

Exclusion Criteria

1. Subject is pregnant or planning to become pregnant during the study duration
2. Subject has a life expectancy of less than one (1) year
3. Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications
4. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No