What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include angioplasty, stenting, and supervised exercise therapy. Angioplasty and stenting, such as the use of the MicroStent® System, can cause side effects like bleeding, infection, blood vessel damage, and restenosis (re-narrowing of the artery). Supervised exercise therapy, while generally safe, may lead to muscle soreness and fatigue. Pharmacologic treatments like cilostazol can cause headaches, diarrhea, and palpitations. Statins, used to manage cholesterol, may lead to muscle pain and liver enzyme abnormalities.

What prior FDA approvals exist?

The FDA has approved several stents for the treatment of Peripheral Arterial Disease (PAD), particularly for maintaining vessel patency after angioplasty. These include bare-metal stents and drug-eluting stents, such as those coated with paclitaxel, which help prevent restenosis. The Zilver PTX stent, for example, is a paclitaxel-coated stent specifically approved for use in the femoropopliteal artery. Additionally, the FDA has approved various pharmacological treatments like cilostazol and statins, which can improve symptoms and reduce cardiovascular events in PAD patients. These treatments aim to enhance blood flow and manage symptoms, similar to the objectives of the MicroStent® System being studied.

What other types of research exist?

Promising novel alternatives to the MicroStent® System for PAD patients include: 1) Zilver PTX polymer-free, paclitaxel-coated stents, which have shown effectiveness in treating femoropopliteal lesions; 2) Viabahn stent grafts, which are also effective for femoropopliteal artery lesions; and 3) SELUTION Sustained-Limus-Release Drug-Eluting Balloon, which uses sirolimus to prevent restenosis and has shown positive six-month outcomes in clinical trials.

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Peripheral Vascular Stent

MicroStent for Peripheral Arterial Disease

N/A

Recruiting

Research Sponsored by Micro Medical Solution, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has a lesion, with ≥ 70% stenosis and ≤ 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries

Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old

Must not have

Subject had a stroke within 3 months of index procedure

Subject presents with acute limb ischemia or acute thrombosis of the target limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death from any cause assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, typical side effects may include pain at the intervention site, bleeding, infection risk, potential damage to blood vessels or surrounding tissues, and reactions related to stent placement like clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke within the last 3 months.

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

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

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I have a history of blood clotting issues.

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I am currently experiencing acute kidney failure.

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

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

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

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

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I currently have an infection that affects my whole body.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death from any cause assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death from any cause assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from perioperative death

Patency of the target lesion

Secondary study objectives

Freedom from major adverse limb event

Freedom from major amputation above the ankle

Frequency and severity of serious adverse events and device and procedure related adverse events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral Arterial Disease (PAD) treatments aim to improve blood flow and reduce symptoms such as claudication and limb-threatening ischemia. The MicroStent® System, similar to other stents, provides structural support to blood vessels, keeping them open after angioplasty. This is crucial as it prevents restenosis, ensuring sustained blood flow to affected limbs. Other common treatments include exercise therapy, which enhances collateral circulation, and pharmacologic therapies like statins and antiplatelet agents, which reduce cardiovascular risk and improve walking distance. These treatments collectively aim to alleviate symptoms, improve quality of life, and prevent severe complications like amputation.

Treatment for intermittent claudication and the effects on walking distance and quality of life.