A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

Peripheral Arterial Disease Clinical Trial

Official title:

A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477604
• Other study ID #: MMS-001
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2022
• Source: Micro Medical Solution, Inc.
• Contact: Kate Mandall
• Phone: 949-292-5466
• Email: kmandall[@]micromedicalsolutions.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT04025008

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

General Inclusion Criteria:

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

2. Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.

3. 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.

4. Subject is willing to comply with all required follow-up visits.

5. Subject life expectancy is =1 year per the Principal Investigator.

Angiographic Inclusion Criteria

6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.

7. 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.

8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm

9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.

General Exclusion Criteria:

1. Subject had a prior or has a planned index limb amputation above the ankle.

2. Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.

3. Subject is pregnant, plans to become pregnant, or is nursing.

4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).

5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.

6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.

7. Subject is in acute renal failure.

8. Subject has an active systemic infection.

9. Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.

10. Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.

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

12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.

13. Subject had a stroke within 3 months of index procedure.

Angiographic exclusion criteria

14. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining =30% residual stenosis with no major procedural complications (e.g embolism).

15. Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining =30% residual stenosis with no major procedural complications (e.g. embolism).

16. Target lesion is within a previously placed stent.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
• Standard PTA
Standard PTA balloon

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center	Aurora	Colorado
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	University of Maryland - Baltimore	Baltimore	Maryland
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	North Jersey Vascular Center	Clifton	New Jersey
United States	Vascular Institute of the Midwest	Davenport	Iowa
United States	Palm Vascular	Fort Lauderdale	Florida
United States	AMI Vascular Institute	Galloway	New Jersey
United States	Advanced Cardiac and Vascular Amputation Prevention Centers	Grand Rapids	Michigan
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	US Cardiovascular	Jefferson Hills	Pennsylvania
United States	FHV Health	Leesburg	Florida
United States	Modern Vascular	Mesa	Arizona
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	AZH/WAVE Vascular Center	Milwaukee	Wisconsin
United States	Brown University	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Eastlake Cardiovascular	Roseville	Michigan
United States	St. Helena Hospital	Saint Helena	California
United States	Advent Health Sebring	Sebring	Florida
United States	Cardiology Consultants	Spartanburg	South Carolina
United States	Cardiovascular Associates of East Texas	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Micro Medical Solution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of the target lesion	Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.	up to 6 months after randomization
Primary	Freedom from perioperative death	Freedom from perioperative death	up to 30 days after randomization
Primary	Freedom from major adverse limb event	Freedom from major adverse limb event	up to 6 months after randomization
Secondary	Freedom from major amputation above the ankle	Freedom from major amputation (above the ankle)	up to 6 months after randomization
Secondary	Reduction in size of ischemic leg/foot ulcers	Reduction in size of ischemic leg/foot ulcers	up to 6 months after randomization
Secondary	Freedom from major adverse limb event	Freedom from major adverse limb event	From date of randomization until the date of death from any cause assessed up to 36 months
Secondary	Frequency and severity of serious adverse events and device and procedure related adverse events	Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.	From date of randomization until the date of death from any cause assessed up to 36 months