Clinical trial NCT03477604: A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Official title: A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Below the knee
Stent
Lead sponsor: Micro Medical Solution, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 177
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patency of the target lesion
timeFrame: up to 6 months after randomization
measure: Freedom from perioperative death
timeFrame: up to 30 days after randomization
measure: Freedom from major adverse limb event
timeFrame: up to 6 months after randomization
Secondary outcomes:
measure: Freedom from major amputation above the ankle
timeFrame: up to 6 months after randomization
measure: Reduction in size of ischemic leg/foot ulcers
timeFrame: up to 6 months after randomization
measure: Freedom from major adverse limb event
timeFrame: From date of randomization until the date of death from any cause assessed up to 36 months
measure: Frequency and severity of serious adverse events and device and procedure related adverse events
timeFrame: From date of randomization until the date of death from any cause assessed up to 36 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: Mesa
country: United States
facility: Copper State Vascular
state: Arizona
city: St. Helena
country: United States
facility: St. Helena Hospital
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: Palm Vascular
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Leesburg
country: United States
facility: FHV Health
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Sebring
country: United States
facility: Advent Health Sebring
state: Florida
city: Davenport
country: United States
facility: Vascular Institute of the Midwest
state: Iowa
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland - Baltimore
state: Maryland
city: Grand Rapids
country: United States
facility: Advanced Cardiac and Vascular Amputation Prevention Centers
state: Michigan
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Clifton
country: United States
facility: North Jersey Vascular Center
state: New Jersey
city: Galloway
country: United States
facility: AMI Vascular Institute
state: New Jersey
city: Jefferson Hills
country: United States
facility: US Cardiovascular
state: Pennsylvania
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Spartanburg
country: United States
facility: Cardiology Consultants
state: South Carolina
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Milwaukee
country: United States
facility: AZH/WAVE Vascular Center
state: Wisconsin
Study officials:
References: