Active — Not RecruitingNot Applicable

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

Austria, Belgium, Germany300 participantsStarted 2019-10-31

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

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

Primary Patency

Timeframe: 6 months post-procedure

Freedom from Perioperative Death and Major Adverse Limb Events (MALE)

Timeframe: 30 days post-procedure

NCT IDNCT04110327

SponsorMicro Medical Solution, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31