An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
This trial has no sites in United States.
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Trial details
- Who runs it
- Micro Medical Solution, Inc.
- Trial code
- NCT04110327
- Record updated
- 29 June 2026
- Original description
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.Read full original descriptionShow less
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Inclusion: 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; For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment; Subject's age is ≥ 18 years; Subject must be willing to sign a patient informed consent form.
Exclusion: Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications; Subject is pregnant or planning to become pregnant during the study duration; Subject has a life expectancy of less than one (1) year; Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.