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

Micro Medical Solutions

Status: Active, not recruiting

Conditions: Critical Lower Limb Ischemia; Peripheral Arterial Disease

Treatments: Device: MicroStent

Study type: Observational

Funder types: Industry

Identifiers

NCT04110327

MMS-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.