MicroStent for Peripheral Arterial Disease

Not currently recruiting at 25 trial locations

Overseen By Kate Mandall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Micro Medical Solution, Inc.

Disqualifiers: Amputation, Osteomyelitis, Pregnancy, Hypercoagulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new device called the MicroStent® System for treating peripheral arterial disease, a condition where narrowed blood vessels in the legs cause poor blood flow. Participants will receive either the MicroStent® System with a procedure called PTA or just PTA alone, a standard treatment to widen blood vessels. The trial seeks participants with critical limb ischemia (severe leg pain due to poor blood flow) who can walk without assistance. Those with a history of leg pain from narrowed blood vessels and who meet these criteria may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of the MicroStent® System for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the MicroStent System is safe for treating infrapopliteal lesions?

Research has shown that the MicroStent is safe for treating peripheral arterial disease. In one study, all patients survived six months after the procedure. About 94% did not experience major limb issues, and almost 96% avoided major amputations. More than 80% of patients had their blood vessels remain open. These results suggest that most patients tolerate the MicroStent well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the MicroStent for peripheral arterial disease because it offers a new approach to treating arterial blockages below the knee. Unlike current treatments, which often involve balloon angioplasty (PTA) alone, the MicroStent system includes a stent that helps keep arteries open after the procedure. This could potentially lead to better blood flow and longer-lasting results compared to standard methods. By integrating the stent into the treatment, the MicroStent aims to reduce the chances of arteries narrowing again, which is a common issue with traditional treatments.

What evidence suggests that this trial's treatments could be effective for peripheral arterial disease?

Research shows that the MicroStent® System holds promise for treating peripheral arterial disease. In this trial, participants will join different treatment arms. One arm will receive the MicroStent System. Studies have shown that all patients were free from POD, a type of complication, after six months. Additionally, 93.9% of patients avoided major limb issues, and 95.9% did not need major amputations. The stent remained open and functional in 80.4% of cases, known as primary patency. These results suggest that the MicroStent System could effectively manage artery problems below the knee. Another arm will receive Standard PTA, serving as an active comparator in this trial. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PTA plus the MicroStent® System or PTA alone for the treatment of infrapopliteal lesions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• MicroStent
• Standard PTA

Trial Overview

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.

How Is the Trial Designed?

Group I: MicroStent and Standard PTA Experimental Treatment 1 Intervention

Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.

Group II: Standard PTA Active Control 1 Intervention

Who Is Running the Clinical Trial?

Micro Medical Solution, Inc.

Lead Sponsor

Trials

2

Recruited

480+

Published Research Related to This Trial

Paclitaxel drug-coated balloons and drug-eluting stents, introduced for treating intermittent claudication, showed better limb revascularization compared to non-coated devices, but recent studies raised concerns about a potential increase in late all-cause mortality associated with these treatments.

In response to these safety concerns, a Vascular Leaders Forum was convened with 100 experts from various fields to investigate the findings and discuss the implications for patient care, aiming to balance the risks and benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? Beckman, JA., White, CJ.[2020]

Citations

1.

jvascsurg.org

jvascsurg.org/article/S0741-5214(24)00179-4/fulltext

The MicroStent HEAL Registry: Interim 6-Month Outcomes

Six-month results showed 100% freedom from POD, 93.9% freedom from major adverse limb events, and 95.9% freedom from major amputation. Primary patency was 80.4% ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04110327

An All-Comers Observational Study of the MicroStent ...

The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03477604

Study Details | NCT03477604 | A Clinical Evaluation of the ...

Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, ...

4.

evtoday.com

evtoday.com/news/micro-medical-solutions-microstent-evaluated-in-european-heal-registry-and-united-states-stand-ide-trial

Micro Medical Solutions Provides Updates on MicroStent ...

The studies are evaluating the company's MicroStent technology in the treatment of patients with chronic limb-threatening ischemia (CLTI)/ ...

5.

micromedicalsolutions.net

micromedicalsolutions.net/news/micro-medical-solutions-achieves-milestone-with-200th-enrollment-in-heal-registry/

Micro Medical Solutions Achieves Milestone with 200th ...

HEAL's research endpoints provide real world evidence of the effectiveness and safety of treatment with the Micro Stent. With enrollment of 200 ...