Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 1:11 PM
Study NCT ID:
NCT02044666
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-05', 'studyFirstSubmitDate': '2014-01-22', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and types of adverse events', 'timeFrame': '180 days'}]}, 'conditionsModule': {'keywords': ['Critical Limb Ischemia', 'Amputation'], 'conditions': ['Ischemia', 'Peripheral Arterial Disease', 'Peripheral Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rutherford stage 4 or 5 or Leriche-Fontaine classification IIIB\n* Patient is unable to be treated by endovascular or surgical means\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding\n* Patient has had a previous surgery within 30 days of the study procedure\n* Patient has a planned surgical or interventional procedure within 30 days after the study procedure\n* Patient has a life expectancy of less than 1 year\n* Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue.\n* Additional restrictions as specified in the protocol'}, 'identificationModule': {'nctId': 'NCT02044666', 'briefTitle': 'Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Pilot Safety Study of Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia', 'orgStudyIdInfo': {'id': '13-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: Micronized Small Intestinal Submucosa (SIS)']}], 'interventions': [{'name': 'Micronized Small Intestinal Submucosa (SIS)', 'type': 'DEVICE', 'description': 'Micronized Small Intestinal Submucosa (SIS)', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kong Teng Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}