Trials / Active Not Recruiting
Active Not RecruitingNCT03477604
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Micro Medical Solution, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MicroStent and Standard PTA | Self-expanding stent and standard PTA balloon |
| DEVICE | Standard PTA | Standard PTA balloon |
Timeline
- Start date
- 2020-03-31
- Primary completion
- 2025-06-05
- Completion
- 2028-03-01
- First posted
- 2018-03-26
- Last updated
- 2026-04-06
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03477604. Inclusion in this directory is not an endorsement.