Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 4:40 PM
Study NCT ID:
NCT01177033
Status:
UNKNOWN
Last Update Posted:
2010-08-06
First Post:
2010-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angioplasty or Bypass Surgery in Intermittent Claudication
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intermittent Claudication', 'Complex Lesions of the Superficial Femoral Artery']}, 'descriptionModule': {'briefSummary': 'CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS\n\nPhase: IV\n\nTITLE OF STUDY\n\nAngioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery\n\nCONDITION\n\nPeripheral arterial occlusive disease (PAOD)\n\nOBJECTIVE(S)\n\nThe objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery.\n\nINTERVENTIONS\n\nIntervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).\n\nDuration of intervention per patient: Dependent on the method of treatment\n\nFollow-up per patient: 24 months\n\nOUTCOMES\n\nPrimary efficacy endpoint:\n\nTwo primary efficacy endpoints will be considered simultaneously in this trial:\n\n(A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of \\>= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR).\n\n(B) Proportion of surviving patients with clinical improvement of \\>= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is able to verbally acknowledge and understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.\n* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol.\n* Age ≥ 50 and ≤ 85 years old.\n* Intermittent claudication (IC) class 2 or 3 (Rutherford) assessed by treadmill testing or 6-Minute Walk Test.\n* Lasting \\>3 months.\n* Failed conservative therapy and the patient's desire for further treatment.\n* Atherosclerotic single or multiple stenoses (\\>50%) or an occlusion of the Superficial Femoral Artery (SFA) with a target lesion length of 10-20 cm without involvement of the common/deep femoral artery and/or the popliteal artery confirmed by duplex ultrasound and angiography.\n* At least one patent tibioperoneal artery with no stenosis \\>50% in diameter. Technical and morphological accessibility for both catheter intervention and bypass surgery.\n* Absence of other disease that would limit exercise (e.g. angina or chronic respiratory disease).\n\nExclusion Criteria:\n\n* \\>50% stenosis or occlusion of the iliac, the common, the deep femoral or the popliteal artery.\n* Surgical reconstruction or catheter intervention on the index leg within the last six months.\n* Unsuitability of treadmill testing / Six-Minute Walk Test. Chronic limb ischemia (intermittent claudication class 2 to 6) on the contralateral leg.\n* Known allergy to contrast agents containing iodine.\n* Contraindication for antiplatelet agents or anticoagulants.\n* Clinically manifested heart insufficiency (NYHA III, IV) and/or uncorrected hyperthyreosis.\n* Serious general disease state with an estimated life expectancy \\< 2 years (ASA IV, V).\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT01177033', 'acronym': 'ABC', 'briefTitle': 'Angioplasty or Bypass Surgery in Intermittent Claudication', 'organization': {'class': 'NETWORK', 'fullName': 'Institut für Klinisch-Kardiovaskuläre Forschung GmbH'}, 'officialTitle': 'ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:', 'orgStudyIdInfo': {'id': 'ISRCTN 39997806'}, 'secondaryIdInfos': [{'id': '2010-021374-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Best endovascular treatment', 'description': 'Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).', 'interventionNames': ['Other: Best endovascular treatment or Best surgical treatment']}, {'label': 'Best surgical treatment', 'description': 'Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).', 'interventionNames': ['Other: Best endovascular treatment or Best surgical treatment']}], 'interventions': [{'name': 'Best endovascular treatment or Best surgical treatment', 'type': 'OTHER', 'description': 'Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).', 'armGroupLabels': ['Best endovascular treatment', 'Best surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gustav Fraedrich, Prof. Dr.', 'role': 'CONTACT', 'email': 'Gustav.Fraedrich@i-med.ac.at', 'phone': '+43 050 50422587'}], 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1160', 'city': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Afshin Assadian, PD Dr', 'role': 'CONTACT', 'email': 'wil1chsek@wienkav.at', 'phone': '+43149150-4101'}], 'facility': 'Wilhelminenhospital Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '52074', 'city': 'Aachen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'M. Jacobs, Prof. Dr.', 'role': 'CONTACT', 'email': 'mjacobs@ukaachen.de', 'phone': '+49-241-8080832'}], 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '86156', 'city': 'Augsburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klaus Wölfle, Prof. Dr.', 'role': 'CONTACT', 'email': 'klaus.woelfle@klinikum-augsburg.de', 'phone': '+49-821-4002655'}], 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '96049', 'city': 'Bamberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Heinz Weber, Dr.', 'role': 'CONTACT', 'email': 'heinz.weber@sozialstiftung-bamberg.de', 'phone': '+49951-50312151'}], 'facility': 'Klinikum am Bruderwald', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '10115', 'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Malte Hegenscheid, Dr.', 'role': 'CONTACT', 'email': 'maltehegenscheid@bundeswehr.org', 'phone': '+493028411291'}], 'facility': 'Bundeswehrkrankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Frauke Verrel, Dr.', 'role': 'CONTACT', 'email': 'frauke.verrel@ukb.uni-bonn.de', 'phone': '+49 22828715109'}], 'facility': 'Uniklinik Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Schmitz-Rixen, Prof. Dr.', 'role': 'CONTACT', 'email': 'schmitz-rixen@em.uni-frankfurt.de', 'phone': '+49 6963015349'}], 'facility': 'Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'S. Debus, Prof. Dr.', 'role': 'CONTACT', 'email': 'debus@uke.de', 'phone': '+4940-741053876'}], 'facility': 'Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '63450', 'city': 'Hanau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hardy Schumacher, Prof. Dr.', 'role': 'CONTACT', 'email': 'hardy_schumacher@klinikum-hanau.de', 'phone': '+49-6181-2962310'}], 'facility': 'Klinikum Hanau', 'geoPoint': {'lat': 50.13423, 'lon': 8.91418}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dittmar Böckler, Prof. Dr.', 'role': 'CONTACT', 'email': 'dittmar.boeckler@med.uni-heidelberg.de', 'phone': '+49 6221 - 566110'}], 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '85049', 'city': 'Ingolstadt', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volker Ruppert, PD Dr', 'role': 'CONTACT', 'email': 'volker.ruppert@klinikum-ingolstadt.de', 'phone': '+49 841-8802425'}], 'facility': 'Klinikum Ingolstadt', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'zip': '76133', 'city': 'Karlsruhe', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Storck, Prof. Dr.', 'role': 'CONTACT', 'email': 'martin.storck@klinikum-karlsruhe.de', 'phone': '+49721-9742301'}], 'facility': 'Städtisches Klinikum Karlsruhe', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '71640', 'city': 'Ludwigsburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johannes Gahlen, Prof.Dr', 'role': 'CONTACT', 'email': 'johannes.gahlen@kliniken-lb.de', 'phone': '+49 7141-9966401'}], 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}, {'zip': '55131', 'city': 'Mainz', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Düber, Prof.Dr', 'role': 'CONTACT', 'email': 'dueber@radiologie.klinik.uni-mainz.de', 'phone': '+49 6131-173208'}], 'facility': 'Klinikum der Johannes Gutenberg Unviersität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'M. Niedergethmann, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '45468', 'city': 'Mühlheim', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Stehr, PD Dr.', 'role': 'CONTACT', 'email': 'Alexander.Stehr@evkmh.de', 'phone': '+49 - 208 - 3092440'}], 'facility': 'Evangelisches Krankenhaus Mühlheim', 'geoPoint': {'lat': 53.52318, 'lon': 9.17204}}, {'zip': '80336', 'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrich Hoffmann, Prof. Dr.', 'role': 'CONTACT', 'email': 'Ulrich.Hoffmann@med.uni-muenchen.de', 'phone': '+49 89 51603601'}], 'facility': 'Klinikum der Universität München, Chirurgische Klinik und Poliklinik Innenstadt', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hans-Henning Eckstein, Prof. Dr.', 'role': 'CONTACT', 'email': 'H.H.Eckstein@lrz.tum.de', 'phone': '+49-89-41402167'}], 'facility': 'Klinikum Rechts der Isar, Technische Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Giovanni Torsello, Prof. Dr.', 'role': 'CONTACT', 'email': 'Giovanni.Torsello@ukmuenster.de', 'phone': '+49251-8345782'}], 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Piotr Kasprzak, PD Dr.', 'role': 'CONTACT', 'email': 'piotr.kasprzak@klinik.uni-regensburg.de', 'phone': '+49 941-9446911'}], 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '67346', 'city': 'Speyer', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gerhard Rümenapf, Prof. Dr.', 'role': 'CONTACT', 'email': 'gerhard.ruemenapf@diakonissen-speyer.de', 'phone': '+49 - 6232-221955'}], 'facility': 'Diakonissen-Stiftungs-Krankenhaus Speyer', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}, {'zip': '70174', 'city': 'Stuttgart', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Hupp, Prof.Dr.', 'role': 'CONTACT', 'email': 't.hupp@klinikum-stuttgart.de', 'phone': '+49711-27833601'}], 'facility': 'Katharinenhospital Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '89075', 'city': 'Ulm', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karl-Heinz Orend, Prof. Dr.', 'role': 'CONTACT', 'email': 'karl-heinz.orend@uniklinik-ulm.de', 'phone': '+49-731-500544001'}], 'facility': 'Universtitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '65199', 'city': 'Wiesbaden', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Achim Neufang, PD Dr.', 'role': 'CONTACT', 'email': 'achim.neufang@hsk-wiesbaden.de'}], 'facility': 'HSK Dr. Horst Schmidt Klinik', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Klinisch-Kardiovaskuläre Forschung GmbH', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Univ.-Prof. Dr. Hans-Henning Eckstein', 'oldOrganization': 'Klinikum Rechts der Isar, Technische Universität München'}}}}