Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02363894
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2015-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEFINITIVE AR Two Year Follow-up Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Event Rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Was a subject in DEFINITIVE AR I\n* Is able and willing to provide written informated consent prior to study specific data collection.\n\nExclusion Criteria:\n\n* Withdrew consent in DEFINITIVE AR I.\n* Was reported dead during DEFINITIVE AR I.'}, 'identificationModule': {'nctId': 'NCT02363894', 'briefTitle': 'DEFINITIVE AR Two Year Follow-up Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study', 'orgStudyIdInfo': {'id': 'CP-1009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects enrolled in DEFINITIVE AR'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Prof. Thomas Zeller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitats Herzzentrum Freiburg - Bad Krozingen, Germany'}, {'name': 'Prof. Gunnar Tepe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}