MicroStent for Peripheral Arterial Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

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

I have a blocked artery in my lower leg that is not longer than 12 cm.

I am between 21 and 90 years old and not pregnant.

My leg has severe circulation problems, classified as Rutherford 4-5.

Exclusion Criteria

I had a stroke within the last 3 months.

I have sudden loss of blood flow or clot in my limb.

I have a large wound on my foot or an infection in my heel bone.

I have a history of blood clotting issues.

I am currently experiencing acute kidney failure.

I am not currently in a research study for a new treatment or device.

My leg artery treatment did not reduce the blockage enough without major issues.

My lower leg treatment was unsuccessful, with complications or over 30% narrowing remaining.

I had a heart attack or chest pain less than 30 days ago.

I currently have an infection that affects my whole body.

I have had or will have an amputation above my ankle.

Treatment Details

The 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.

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