MicroStent for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
+25 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Micro Medical Solution, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a small tube-like device called the MicroStent® System, used along with a procedure that widens blood vessels, in patients with peripheral arterial disease who have blockages in the arteries below the knee. The stent helps keep the arteries open to ensure better blood flow. The Micro stent (MS) is a balloon expandable stent that allows the treatment of narrowings in distant and twisted coronary arteries.
Research Team
Eligibility Criteria
This trial is for adults aged 21-90 with Peripheral Arterial Disease affecting leg arteries below the knee, who can consent to participate and follow-up. They must have a specific type of blockage in their leg artery and be able to undergo treatment without severe risks from other health issues or recent major cardiovascular events.Inclusion Criteria
The target lesion is in a blood vessel with a diameter between 2.5 and 4.5 millimeters.
The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent
Subject is willing to comply with all required follow-up visits
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Exclusion Criteria
The area to be treated is inside a stent that has already been implanted.
I had a stroke within the last 3 months.
I have sudden loss of blood flow or clot in my limb.
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Treatment Details
Interventions
- MicroStent (Peripheral Vascular Stent)
- Standard PTA (Procedure)
Trial OverviewThe STAND trial is testing if adding the MicroStent® System to standard balloon angioplasty (PTA) improves outcomes for patients with arterial disease below the knee compared to PTA alone. Participants are randomly assigned to one of these two treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MicroStent and Standard PTAExperimental Treatment1 Intervention
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Group II: Standard PTAActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Micro Medical Solution, Inc.
Lead Sponsor
Trials
2
Recruited
480+