Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT03477604
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency of the target lesion', 'timeFrame': 'up to 6 months after randomization', 'description': 'Primary patency defined as freedom from target lesion occlusion with no clinically driven target lesion reintervention, or major amputation.'}, {'measure': 'Freedom from perioperative death', 'timeFrame': 'up to 30 days after randomization', 'description': 'Freedom from perioperative death'}, {'measure': 'Freedom from major adverse limb event', 'timeFrame': 'up to 6 months after randomization', 'description': 'Freedom from major adverse limb event'}], 'secondaryOutcomes': [{'measure': 'Freedom from major amputation above the ankle', 'timeFrame': 'up to 6 months after randomization', 'description': 'Freedom from major amputation (above the ankle)'}, {'measure': 'Reduction in size of ischemic leg/foot ulcers', 'timeFrame': 'up to 6 months after randomization', 'description': 'Reduction in size of ischemic leg/foot ulcers'}, {'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', 'description': 'Freedom from major adverse limb event'}, {'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', 'description': 'Frequency and severity of serious adverse events and device and procedure-related adverse events at any time during the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Below the knee', 'Stent'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria:\n\n1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.\n2. 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.\n3. 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.\n4. Subject is willing to comply with all required follow-up visits.\n5. Subject life expectancy is ≥1 year per the Principal Investigator.\n\n Angiographic Inclusion Criteria\n6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (\\<50% stenosis) inframalleolar outflow vessel.\n7. 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.\n8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm\n9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.\n\nGeneral Exclusion Criteria:\n\n1. Subject had a prior or has a planned index limb amputation above the ankle.\n2. Subject has a wound/ulcer on the forefoot with a surface area \\>4cm² or osteomyelitis involving the calcaneus bone.\n3. Subject is pregnant, plans to become pregnant, or is nursing.\n4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).\n5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.\n6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.\n7. Subject is in acute renal failure.\n8. Subject has an active systemic infection.\n9. 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.\n10. 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.\n11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.\n12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.\n13. Subject had a stroke within 3 months of index procedure.\n\n Angiographic exclusion criteria\n14. 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).\n15. 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).\n16. Target lesion is within a previously placed stent."}, 'identificationModule': {'nctId': 'NCT03477604', 'briefTitle': 'A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)', 'nctIdAliases': ['NCT04025008'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Micro Medical Solution, Inc.'}, 'officialTitle': 'A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)', 'orgStudyIdInfo': {'id': 'MMS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MicroStent and Standard PTA', 'description': 'Implant of the MicroStent peripheral vascular stent system for treatment of arterial lesions below the knee.', 'interventionNames': ['Device: MicroStent and Standard PTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard PTA', 'interventionNames': ['Device: Standard PTA']}], 'interventions': [{'name': 'MicroStent and Standard PTA', 'type': 'DEVICE', 'description': 'Self-expanding stent and standard PTA balloon', 'armGroupLabels': ['MicroStent and Standard PTA']}, {'name': 'Standard PTA', 'type': 'DEVICE', 'description': 'Standard PTA balloon', 'armGroupLabels': ['Standard PTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiovascular Associates of the Southeast', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85203', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Copper State Vascular', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '94574', 'city': 'St. Helena', 'state': 'California', 'country': 'United States', 'facility': 'St. Helena Hospital', 'geoPoint': {'lat': 38.50519, 'lon': -122.47026}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Regional VA Medical Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Vascular', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'First Coast Cardiovascular Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'FHV Health', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33872', 'city': 'Sebring', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Sebring', 'geoPoint': {'lat': 27.49559, 'lon': -81.44091}}, {'zip': '52807', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Vascular Institute of the Midwest', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland - Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Advanced Cardiac and Vascular Amputation Prevention Centers', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart and Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '07013', 'city': 'Clifton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'North Jersey Vascular Center', 'geoPoint': {'lat': 40.85843, 'lon': -74.16376}}, {'zip': '08205', 'city': 'Galloway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AMI Vascular Institute', 'geoPoint': {'lat': 39.48788, 'lon': -74.47598}}, {'zip': '15025', 'city': 'Jefferson Hills', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'US Cardiovascular', 'geoPoint': {'lat': 40.29118, 'lon': -79.93199}}, {'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cardiology Consultants', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiothoracic and Vascular Surgeons', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '53221', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'AZH/WAVE Vascular Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Micro Medical Solution, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}