Status:
ACTIVE_NOT_RECRUITING
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Lead Sponsor:
Micro Medical Solution, Inc.
Conditions:
Peripheral Arterial Disease
Critical Lower Limb Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Detailed 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...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
October 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04110327
Start Date
October 31 2019
End Date
December 31 2028
Last Update
September 22 2025
Active Locations (10)
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1
Univ.-Klinikum LKH Graz
Graz, Austria
2
OLV Hospital
Aalst, Belgium
3
A.Z. Sint-Blasius
Dendermonde, Belgium
4
ZOL Genk
Genk, Belgium