Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT04110327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency', 'timeFrame': '6 months post-procedure', 'description': 'Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)'}, {'measure': 'Freedom from Perioperative Death and Major Adverse Limb Events (MALE)', 'timeFrame': '30 days post-procedure', 'description': 'Freedom from all-cause death or major adverse limb events. Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.'}], 'secondaryOutcomes': [{'measure': 'Freedom from Major Adverse Limb Events', 'timeFrame': '6, 12, 24 Months', 'description': 'Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.'}, {'measure': 'Freedom from Major Amputation', 'timeFrame': '6, 12, 24 Months', 'description': 'Freedom from above-ankle amputation in the target limb'}, {'measure': 'Freedom from Clinically Driven Target Lesion Revascularization (TLR)', 'timeFrame': '6, 12, 24 Months', 'description': 'Freedom from any revascularization procedure with involvement of the target lesion that is due to complaints of leg pain or worsening leg pain, a progressing, non-healing ulcer, or new ulcer formation with or without the presence of an abnormal non-invasive test.'}, {'measure': 'Wound Healing', 'timeFrame': '30 days, 6, 12, 24 Months', 'description': 'Wounds will be identified at the baseline visit and classified as fully healed or not healed at each follow up visit.'}, {'measure': 'Device Success', 'timeFrame': 'Procedure', 'description': 'Operator assessment of successful device deployment and full coverage of the lesion as intended'}, {'measure': 'Technical Success', 'timeFrame': 'Procedure', 'description': 'Attainment of less than or equal to 30% residual stenosis by visual estimate in the treated lesion using only the study device according to the IFU (i.e. including post dilation at the discretion of the investigator)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MicroStent', 'Below the Knee', 'CLI', 'Below the Ankle', 'CLTI'], 'conditions': ['Peripheral Arterial Disease', 'Critical Lower Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.', 'detailedDescription': 'Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled:\n\nThe objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include any subject with symptomatic peripheral arterial disease (PAD) that require intervention with the MicroStent™ System.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use\n2. For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment\n3. Subject's age is ≥ 18 years.\n4. Subject must be willing to sign a patient informed consent form.\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant during the study duration\n2. Subject has a life expectancy of less than one (1) year\n3. Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications\n4. Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment."}, 'identificationModule': {'nctId': 'NCT04110327', 'acronym': 'HEAL', 'briefTitle': 'An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Micro Medical Solution, Inc.'}, 'officialTitle': 'An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'MMS-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MicroStent', 'type': 'DEVICE', 'description': 'Treatment of arterial stenosis or occlusion with the MicroStent Peripheral Vascular Stent System'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Univ.-Klinikum LKH Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'A.Z. Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'ZOL Genk', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Hochsauerland - Karolinen Hospital', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'University Heart Center Freiburg - Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Abano Terme', 'country': 'Italy', 'facility': 'Policlinico Abano Terme', 'geoPoint': {'lat': 45.35753, 'lon': 11.78725}}, {'city': 'Cotignola', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Micro Medical Solution, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}