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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
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

Study Summary

This trial is testing whether a stent system is safe and effective for treating peripheral arterial disease.

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.Check my eligibility
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.See study design
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.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from perioperative death
Patency of the target lesion
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Micro Medical Solution, Inc.Lead Sponsor
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
250 Patients Enrolled for Peripheral Arterial Disease

Media Library

MicroStent (Peripheral Vascular Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03477604 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different venues is this trial being managed?

"Across the US, 18 locations are running this clinical trial. These include Cardiothoracic and Vascular Surgeons in Austin, Cardiology Consultants in Spartanburg, US Cardiovascular in Jefferson Hills, among other centres."

Answered by AI

How many participants are receiving the therapy being tested in this clinical trial?

"Affirmative. Clinicaltrials.gov holds information which reveals that recruitment is currently ongoing for this clinical study, first published on June 19th 2019 and most recently modified October 3rd 2022. A total of 177 individuals must be enrolled at 18 different medical centres across America."

Answered by AI

Does this research endeavor currently admit participants?

"Indeed, the evidence available on clinicaltrials.gov reveals that this research initiative is still recruiting participants. First unveiled in June 2019 and last updated October 2022, 177 volunteers are needed at 18 distinct medical facilities around the country."

Answered by AI

What is the principal objective of this experiment?

"This carefully monitored clinical trial seeks to establish Patency of the target lesion over a period of around 30 days after randomization. Secondary goals include Freedom from major amputation above the ankle, Frequency and severity of serious adverse events and device-related adverse events during the study, as well as Reduction in size of ischemic leg/foot ulcers."

Answered by AI

Who else is applying?

What site did they apply to?
Modern Vascular
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
2019. "A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03477604.
All > Rhode Island > Pad
~30 spots leftby Apr 2025
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