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

Peripheral Arterial Disease Clinical Trial

— STAND  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04025008
• Other study ID #: MMS-001-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: August 2021

Study information

• Verified date: July 2019
• 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

This prospective pivotal study is a double arm, randomized multi-center study evaluating the safety and performance of the MicroStent peripheral vascular stent system for use in arterial lesions below the knee. A total of 177 subjects will be enrolled at up to 25 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days and 6 months, respectively, post-implant.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 177
• Est. completion date: August 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

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 or percutaneous transluminal angioplasty (PTA)
Intravascular treatment

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Rush University Medical Center	Chicago	Illinois
United States	North Jersey Vascular Center	Clifton	New Jersey
United States	Ohio Health Riverside Methodist	Columbus	Ohio
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Advanced Cardiac and Vascular Amputation Prevention Center	Grand Rapids	Michigan
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Premier Vascular Access and Imaging Center	Knoxville	Tennessee
United States	AZH/WAVE Vascular Center	Milwaukee	Wisconsin
United States	New York University - Langone Health	New York	New York
United States	Einstein Heart and Vascular	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Eastlake Cardiovascular	Roseville	Michigan
United States	Advent Health Sebring	Sebring	Florida
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	Freedom from perioperative death (POD)	Primary Safety Endpoint	30 days post index procedure
Primary	Freedom from major adverse limb event (MALE)	Primary Safety Endpoint	6 months post index procedure
Primary	Freedom from major amputation	Primary Effectiveness Endpoint	6 months post index procedure
Primary	Freedom from target lesion occlusion with no clinically driven target lesion reintervention (TLR)	Primary Effectiveness Endpoint	6 months post index procedure
Secondary	Freedom from major adverse limb event (MALE)	Secondary Safety Endpoint #1	30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post index procedure
Secondary	Frequency and severity of serious adverse events and device and procedure-related adverse events.	Secondary Safety Endpoint #2	Post randomization, 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post randomization
Secondary	Freedom from major amputation (above the ankle)	Secondary Effectiveness Endpoint #1	6 months post index procedure
Secondary	Reduction in size of ischemic leg/foot ulcers	Secondary Effectiveness Endpoint #2	6 months post index procedure