A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03477604|
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : October 4, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: MicroStent and Standard PTA Device: Standard PTA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)|
|Actual Study Start Date :||June 19, 2019|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2026|
Experimental: MicroStent and Standard PTA
Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.
Device: MicroStent and Standard PTA
Self-expanding stent and standard PTA balloon
|Active Comparator: Standard PTA||
Device: Standard PTA
Standard PTA balloon
- Patency of the target lesion [ Time Frame: 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 [ Time Frame: up to 30 days after randomization ]Freedom from perioperative death
- Freedom from major adverse limb event [ Time Frame: up to 6 months after randomization ]Freedom from major adverse limb event
- Freedom from major amputation above the ankle [ Time Frame: up to 6 months after randomization ]Freedom from major amputation (above the ankle)
- Reduction in size of ischemic leg/foot ulcers [ Time Frame: up to 6 months after randomization ]Reduction in size of ischemic leg/foot ulcers
- Freedom from major adverse limb event [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
General Inclusion Criteria:
- Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.
- 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.
- 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.
- Subject is willing to comply with all required follow-up visits.
Subject life expectancy is ≥1 year per the Principal Investigator.
Angiographic Inclusion Criteria
- Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.
- 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.
- Target lesion has a reference vessel diameter of 2.5 - 4.5 mm
- The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.
General Exclusion Criteria:
- Subject had a prior or has a planned index limb amputation above the ankle.
- Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.
- Subject is pregnant, plans to become pregnant, or is nursing.
- Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).
- Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.
- Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.
- Subject is in acute renal failure.
- Subject has an active systemic infection.
- 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.
- 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.
- Subject presents with acute limb ischemia or acute thrombosis of the target limb.
- Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.
Subject had a stroke within 3 months of index procedure.
Angiographic exclusion criteria
- 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).
- 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).
- Target lesion is within a previously placed stent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477604
|Contact: Kate Mandallemail@example.com|
|Responsible Party:||Micro Medical Solution, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 26, 2018 Key Record Dates|
|Last Update Posted:||October 4, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Below the knee
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases