MicroStent for Peripheral Arterial Disease

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

177 Participants Needed

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.

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 data supports the effectiveness of the treatment MicroStent, Standard PTA for Peripheral Arterial Disease?

The German guideline on peripheral artery disease suggests that endovascular techniques, like the use of stents, are recommended for revascularization in patients with critical limb ischemia, indicating their effectiveness in improving blood flow in blocked arteries. ^{1 2 3 4 5}

Is the MicroStent generally safe for use in humans?

There is some concern about the safety of drug-coated devices like paclitaxel-coated balloons and stents, which have been linked to higher mortality rates in some studies. However, other studies have not found a difference in long-term mortality, and the FDA has called for more research to better understand the risks. ^{1 6 7 8 9}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The prospective GermanVasc cohort study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of optimal long-term management of multiple cardiovascular risk factors (CVD) on walking and quality of life in patients with peripheral artery disease (PAD): protocol for randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Measuring walking impairment in patients with intermittent claudication: psychometric properties of the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Limb ischemia: medical therapy trial update. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Femoral-popliteal peripheral artery disease: From symptom presentation to management and treatment controversies. [2022]