Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-02-20 @ 6:07 PM
Study NCT ID:
NCT02307292
Status:
UNKNOWN
Last Update Posted:
2015-01-12
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Post Market Surveillance Q3-registry (POLARIS)
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-09', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from target lesion revascularization', 'timeFrame': 'at 12 months', 'description': 'Clinically driven'}], 'secondaryOutcomes': [{'measure': 'Binary restenosis/ reocclusion', 'timeFrame': 'at 12 months', 'description': 'Defined as peak systolic velocity tatio (PSVR) \\> 2.4'}, {'measure': 'Target limb amputation at the index leg (major and minor separately)', 'timeFrame': 'at 12 months'}, {'measure': 'All-cause death', 'timeFrame': 'at 12 months'}, {'measure': 'Change in resting ankle brachial index (ABI)', 'timeFrame': 'From baseline to 12 and 24 months'}, {'measure': 'Change in Rutherford Classification', 'timeFrame': 'From baseline to 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Superficial femoral artery', 'Self Expanding Stent System'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34994234', 'type': 'DERIVED', 'citation': 'Thieme M, Arjumand J, Spanagel M, Tepe G, Blessing E, Kroeg B, Reichert V, Betge S, Wickenhofer R, Tessarek J, Ingwersen M, Krankenberg H. Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry. J Endovasc Ther. 2022 Dec;29(6):904-912. doi: 10.1177/15266028211067726. Epub 2022 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with single significant (\\>50%) superficial femoral artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Single target de novo superficial femoral artery lesion (angiographic evidence of \\>50% Stenosis or occlusion) by visual estimate\n* Rutherford category II-IV\n* At least one patent outflow artery to the ankle.\n* Patient signed the informed consent\n\nExclusion Criteria:\n\n* Patient with acute or subacute Thrombus\n* Patients with hyperkoagulopathy\n* Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible\n* Pregnancy or positive pregnancy test\n* Previous enrolment in this Trial or other industrial Trials\n* Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure'}, 'identificationModule': {'nctId': 'NCT02307292', 'acronym': 'Q3-Registry', 'briefTitle': 'Prospective, Post Market Surveillance Q3-registry (POLARIS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'QualiMed Innovative Medizinprodukte GmbH'}, 'officialTitle': 'Prospective, Non-randomized Post Market Surveillance Registry to Document the Clinical Performance in Routine Clinical Practice of the POLARIS Peripheral Vascular Self Expanding Stent System.', 'orgStudyIdInfo': {'id': 'QualiMed'}}, 'armsInterventionsModule': {'interventions': [{'name': 'POLARIS Peripheral Vascular Self Expanding Stent System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29549', 'city': 'Bad Bevensen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hans Krankenberg, MD, PhD', 'role': 'CONTACT', 'email': 'h.krankenberg@hgz-bb.de', 'phone': '+495821821157'}], 'facility': 'HGZ Bad Bevensen, Department of Angiology', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}], 'centralContacts': [{'name': 'Sigrid Krimmer-Quendler, PhD', 'role': 'CONTACT', 'email': 'quendler@qualimed.de', 'phone': '+40417165780'}], 'overallOfficials': [{'name': 'Hans Krankenberg, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Center Bad Bevensen, Department of Angiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QualiMed Innovative Medizinprodukte GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Hans Krankenberg', 'investigatorAffiliation': 'Herz- und Gefaesszentrum Bad Bevensen'}}}}