Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00437905
Status:
TERMINATED
Last Update Posted:
2007-02-21
First Post:
2007-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2007-02-20', 'studyFirstSubmitDate': '2007-02-20', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)'}], 'secondaryOutcomes': [{'measure': 'occurence of restenosis within 6 months after endovascular treatment'}]}, 'conditionsModule': {'keywords': ['peripheral vascular disease', 'percutaneous transluminal angioplasty', 'cutting balloon', 'balloon angioplasty', 'randomized controlled trial', 'restenosis', 'inflammation'], 'conditions': ['Peripheral Vascular Disease', 'Intermittent Claudication', 'Atherosclerosis', 'Angioplasty']}, 'referencesModule': {'references': [{'pmid': '18270378', 'type': 'DERIVED', 'citation': 'Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial. Radiology. 2008 Apr;247(1):267-72. doi: 10.1148/radiol.2471070749. Epub 2008 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.', 'detailedDescription': 'Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment.\n\nWith the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation.\n\nThe promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or critical limb ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length\n\nExclusion Criteria:\n\n* Previous bypass surgery at the site of treatment,\n* Previous stent placement at or immediatly adjacent to target lesion,\n* History of anti-platelet-therapy intolerance or adverse reaction to heparin,\n* Bleeding diathesis,\n* Creatinine \\> 2,5 mg/dL,\n* Active bacterial infection,\n* Allergy to contrast media'}, 'identificationModule': {'nctId': 'NCT00437905', 'briefTitle': 'Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Version 2.0-12/2003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'angioplasty', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jasmin Amighi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}, {'name': 'Martin Schillinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}, {'name': 'Manfred Cejna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}}}}