Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-06 @ 2:38 PM
Study NCT ID:
NCT01378260
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2011-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.', 'timeFrame': '12-Months Post-Index Date', 'description': 'The primary outcome of the study, and the outcome on which the study is powered, is the change in score on the WIQ from the baseline assessment to the 12-month assessment. There are three subscales within the WIQ; summary scores will be calculated separately for each - the walk distance, walk speed, stair climb.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral Arterial Disease', 'Claudication', 'Comparative Effectiveness Research', 'PAD Study', 'PAD', 'atherosclerosis', 'Intermittent claudication', 'leg pain'], 'conditions': ['Peripheral Arterial Disease', 'Claudication']}, 'descriptionModule': {'briefSummary': 'The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses;\n\nHypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management.\n\nHypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients being seen by a physician with newly diagnosed or established claudication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of claudication\n2. Be undergoing one of three treatments for claudication:\n\n * Surgical bypass (use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral or popliteal artery)\n * Endovascular therapy (angioplasty and/or stent to treat lesions in the superficial femoral, common femoral or popliteal artery)\n * Medical management (i.e. smoking cessation, walking therapy, long-term monitoring by physician)\n\nExclusion Criteria:\n\n1. those with documented acute ischemia, rest pain or ulceration\n2. those with claudication determined to be of aortic or iliac origin\n3. those with claudication that is not caused by atherosclerotic disease\n4. those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)\n5. those who otherwise refuse to participate (assessed in patient screen)\n6. those who have a diagnosis of dementia confirmed in their medical record\n7. those who are not English speaking\n8. children and young adults up to and including age 20-years'}, 'identificationModule': {'nctId': 'NCT01378260', 'briefTitle': 'Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)', 'orgStudyIdInfo': {'id': '40153'}, 'secondaryIdInfos': [{'id': 'R01HS2002501'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical Bypass', 'description': 'use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery'}, {'label': 'Endovascular Therapy', 'description': 'angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery'}, {'label': 'Medical Management', 'description': 'Documentation of the following in the medical record:\n\ni. Walking/physical therapy to improve endurance was recommended; ii. For tobacco users, tobacco cessation was recommended; iii. Prescribing pentoxifylline (Trental) or cilostazol (pletal) iv. Ongoing care by physician for treatment of claudication'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Lake Washington Vascular', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'PeaceHealth St. Joseph Medical Center', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Everett', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Hospital and Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'St. Joseph Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Tacoma General Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'David R Flum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Flum', 'investigatorAffiliation': 'University of Washington'}}}}