Peripheral Arterial Disease
Conditions
Keywords
Below the knee, Stent
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.
Interventions
DEVICEMicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
DEVICEStandard PTA
Standard PTA balloon
Sponsors
Micro Medical Solution, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency of the target lesion | up to 6 months after randomization | Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation. |
| Freedom from perioperative death | up to 30 days after randomization | Freedom from perioperative death |
| Freedom from major adverse limb event | up to 6 months after randomization | Freedom from major adverse limb event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major amputation above the ankle | up to 6 months after randomization | Freedom from major amputation (above the ankle) |
| Reduction in size of ischemic leg/foot ulcers | up to 6 months after randomization | Reduction in size of ischemic leg/foot ulcers |
| Freedom from major adverse limb event | From date of randomization until the date of death from any cause assessed up to 36 months | Freedom from major adverse limb event |
| Frequency and severity of serious adverse events and device and procedure related adverse events | From date of randomization until the date of death from any cause assessed up to 36 months | Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study. |
Countries
United States
Outcome results
None listed