Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-02 @ 2:58 AM
Study NCT ID:
NCT00660634
Status:
COMPLETED
Last Update Posted:
2008-04-28
First Post:
2008-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angioplasty in Peripheral Arterial Disease and Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-25', 'studyFirstSubmitDate': '2008-04-10', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of Flow-mediated Dilation', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Improvement of white blood cell count', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral arterial obstructive disease', 'Intermittent Claudication', 'Endovascular treatment', 'Flow-mediated dilation'], 'conditions': ['Peripheral Arterial Obstructive Disease', 'Intermittent Claudication']}, 'descriptionModule': {'briefSummary': 'To investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity', 'detailedDescription': 'Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis affecting a large proportion of the aged population. It is associated with a more or less severe impairment in functional activity and with an increased risk of future cardiovascular events. In PAD patients, an increased inflammatory status and a depressed endothelial function, assessed as flow-mediated dilation of the brachial artery have been demonstrated. Moreover, a prognostic value has been found in PAD patients for both inflammatory parameter and flow-mediated dilation (FMD). One of the reasons of the increased inflammatory activation and endothelial dysfunction in PAD patients could be the ischemia-reperfusion injury associated with intermittent claudication. The hypothesis is that repeated episodes of acute inflammation and endothelial dysfunction following ischemia-reperfusion injury linked to intermittent claudication could be in part responsible for the increased inflammatory status and chronically depressed endothelial dysfunction of these patients. Taking into account these considerations, it is reasonable to assume that the correction of leg ischemia by interventional procedure, such as peripheral transluminal angioplasty (PTA) should determine a reduction in inflammatory mediators and an improvement in endothelial function.\n\nThe study is a prospective, open, randomised, controlled, single-centre, follow-up evaluation, assessing the efficacy of peripheral catheter interventions in patients with symptomatic PAD on endothelial dysfunction and plasmatic procoagulant activity. Patients will be randomly assigned to immediate revascularization or to no treatment for one month. The assessment of parameters (brachial artery flow-mediated and nitrate-mediated dilation, plasma levels of C reactive protein, fibrinogen, microparticles and coagulation factors) will be performed at baseline and after 4 weeks in both, patients undergoing interventional procedures and in those, who will not be treated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral arterial disease\n* femoro-popliteal lesion\n* successful endovascular treatment of lesion\n\nExclusion Criteria:\n\n* persistent claudication after revascularization in arm A\n* inflammatory or neoplastic disease\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00660634', 'acronym': 'PTA-PAD-FMD', 'briefTitle': 'Angioplasty in Peripheral Arterial Disease and Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'The Effect of Angioplasty in Peripheral Arterial Disease on Endothelial Function', 'orgStudyIdInfo': {'id': '85/2004'}, 'secondaryIdInfos': [{'id': 'SHF2006'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'B'}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Endovascular angioplasty/stenting', 'interventionNames': ['Procedure: Endovascular Revascularization']}], 'interventions': [{'name': 'Endovascular Revascularization', 'type': 'PROCEDURE', 'description': 'Angioplasty/Stenting of femoro-popliteal lesions', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marc J Husmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Angiology Division, University Hospital of Berne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. med. Marc Husmann/Prof. I Baumgartner', 'oldOrganization': 'Angiology Div. University Hospital of Berne'}}}}