Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-02 @ 7:05 AM
Study NCT ID:
NCT02698358
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency', 'timeFrame': '12 months', 'description': 'Absence of restenosis \\>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months'}], 'secondaryOutcomes': [{'measure': 'Target lesion revascularization rate', 'timeFrame': '12 months'}, {'measure': 'Stent fracture rate', 'timeFrame': '12 months'}, {'measure': 'Quality of life by standardized questionnaires', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral artery disease, Iliac artery, nitinol stent, restenosis'], 'conditions': ['Iliac Artery Disease']}, 'descriptionModule': {'briefSummary': "* Prospective, single-arm, multi-center registry study\n* A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included.\n* Patients will be followed clinically for 12 months after the procedure.\n* Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.\n* Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.\n* Quality of life by standardized questionnaires (at baseline \\& at 1 \\& 12 months)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Iliac artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19 years of older\n2. Symptomatic peripheral artery disease:\n\n * Moderate or severe claudication (Rutherford category 2 or 3)\n * Critical limb ischemia (Rutherford category 4)\n3. Iliac artery lesions with stenosis \\> 50%\n4. ABI \\<0.9\n5. Patients with signed informed consent\n\nExclusion Criteria:\n\n1. Acute critical limb ischemia\n2. Severe critical limb ischemia (Rutherford category 5 or 6)\n3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents\n4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)\n5. Bypass graft lesions\n6. Age \\> 85 years\n7. Severe hepatic dysfunction (\\> 3 times normal reference values)\n8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis\n9. LVEF \\< 40% or clinically overt congestive heart failure\n10. Pregnant women or women with potential childbearing\n11. Life expectancy \\<1 year due to comorbidity\n12. Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)'}, 'identificationModule': {'nctId': 'NCT02698358', 'briefTitle': 'Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2015-0075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'K-EPIC', 'description': 'Patients with femoropopliteal artery disease undergoing endovascular therapy using Epic stent (Boston Scientific).', 'interventionNames': ['Device: Epic stent (Boston Scientific)']}], 'interventions': [{'name': 'Epic stent (Boston Scientific)', 'type': 'DEVICE', 'armGroupLabels': ['K-EPIC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}