Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT01911403
Status:
TERMINATED
Last Update Posted:
2019-02-19
First Post:
2011-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
AGIR Study: Angio-Seal in Interventional Radiology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vilaresmorgado@iol.pt', 'phone': '+351 22 551 2100', 'title': 'Dr. Paulo Morgado', 'organization': 'Hospital de Sao Joao, E.P.E.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study has been early terminated on 15 May 2014 due to low enrollment rate and the publication of other larger studies about closure device versus manual compression.This lead to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': '2 weeks (+/- 1 week)', 'eventGroups': [{'id': 'EG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal', 'otherNumAtRisk': 61, 'otherNumAffected': 7, 'seriousNumAtRisk': 61, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression', 'otherNumAtRisk': 62, 'otherNumAffected': 2, 'seriousNumAtRisk': 62, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Hematoma', 'notes': 'BIGGER BRUISE : SMALL HEMATOMA LESS THAN 6 CM SIGNALED BY THE PATIENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'FAILURE OF INTRODUCTION OF THE INTRODUCER OF THE ANGIO-SEAL WITH SIGNIFICANT BLEEDING.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise', 'notes': 'BIGGER BRUISE OF THE PUNCTURE AREA AND WENT TO A GENERAL PRACTITIONER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache and vomits', 'notes': 'ACUTE HEADACHE + ONE TIME VOMITING AFTER CAROTID STENTING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'HEMATOMA AFTER 5 DAYS OF INTERVENTIONAL PROCEDURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise', 'notes': 'BRUISE IN THE PUNCTION AREA STILL PRESENT AT PHONE CALL VISIT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'BLEEDING AFTER CLOSURE PROCEDURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'BLEEDING AFTER CLOTURE PROCEDURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'SLIGHT PAIN AT PUNCTURE SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'HEMATOMA DURING THE PROCEDURE RELATED TO CALCIFICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'SMALL HAEMATOMA (+/- 1 CM)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'PAIN IN THE PUNCTURE AREA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Deterioration of general condition', 'notes': 'DETERIORATION OF THE GENERAL CONDITION OF THIS GERIATRIC PATIENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'BLEEDING OF THE PUNCTURE SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Perforation femoral artery', 'notes': 'PERFORATION SUPERFICIAL FEMORAL ARTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Significant bleeding', 'notes': 'SIGNIFICANT BLEEDING AFTER MANUAL COMPRESSION WITH PROLONGATION OF MANUAL COMPRESSION AND PROLONGED HOSPITAL STAY.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'HEMATOMA AFTER 24 HOURS AT PUNCTURE SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Abcess', 'notes': 'HEPATIC ABSCESS. DISCHARGE ON 3/06/2011', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edematoascitis', 'notes': 'FEVER, EDEMATOASCITIS DECOMPENSATIS, INFERIOR EXTREMITIES CELLULITIS GREATER IN COUNTER LATERAL PUNCTION SITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Minor Stroke', 'notes': 'MINOR STROKE LEFT SIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'SERIOUS URINARY TRACT INFECTION IN AN ELDERLY PERSON', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel stenosis', 'notes': 'PROLONGED PAIN AT THE PUNCTURE SITE. VESSEL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Mobilization Time Between 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At discharge', 'description': 'Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Mobilization Time Between 4-48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At discharge', 'description': 'Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Any Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)', 'description': 'Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.\n\nThe complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Time to Hemostasis Between 0-4 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At puncture closure', 'description': 'Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Time to Hemostasis Between 4-60 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At puncture closure', 'description': 'Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge From Interventional Radiology Department', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'OG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '9.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At discharge', 'description': 'Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Angio-Seal™ Deployment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}], 'classes': [{'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At puncture closure', 'description': 'According the physician criteria, it will be "YES" If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients in the Angio-Seal arm is analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'FG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal\n\nAngio-Seal: Closure procedure by angio-Seal'}, {'id': 'BG001', 'title': 'Manual Compression', 'description': 'Closure procedure by manual compression\n\nManual compression: Closure procedure by Manual compression'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.77', 'spread': '15.15', 'groupId': 'BG000'}, {'value': '60.92', 'spread': '13.55', 'groupId': 'BG001'}, {'value': '60.84', 'spread': '14.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'whyStopped': 'Low enrollment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2011-04-14', 'resultsFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-26', 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Mobilization Time Between 0-4 Hours', 'timeFrame': 'At discharge', 'description': 'Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Mobilization Time Between 4-48 Hours', 'timeFrame': 'At discharge', 'description': 'Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.'}, {'measure': 'Number of Patients With Any Complications', 'timeFrame': 'At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)', 'description': 'Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.\n\nThe complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion.'}, {'measure': 'Number of Patients With Time to Hemostasis Between 0-4 Minutes', 'timeFrame': 'At puncture closure', 'description': 'Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".'}, {'measure': 'Number of Patients With Time to Hemostasis Between 4-60 Minutes', 'timeFrame': 'At puncture closure', 'description': 'Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".'}, {'measure': 'Time to Discharge From Interventional Radiology Department', 'timeFrame': 'At discharge', 'description': 'Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.'}, {'measure': 'Percentage of Patients With Angio-Seal™ Deployment Success', 'timeFrame': 'At puncture closure', 'description': 'According the physician criteria, it will be "YES" If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral Artery puncture'], 'conditions': ['Vascular Access Complication']}, 'descriptionModule': {'briefSummary': 'Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access.\n\nIt is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.', 'detailedDescription': 'Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression.\n\nPatients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week).\n\nThe randomization will be stratified according to the type of procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)\n* Patient available for follow-up at 2 weeks\n* Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.\n\nExclusion Criteria:\n\n* Access unsuitable for use of Angio-Sea\n* Presence of calcification at the puncture site\n* Presence of visible hematoma at the end of the procedure\n* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.\n* Patients who are pregnant.\n* Patients currently participating in a clinical investigation that includes an active treatment arm.\n* Contraindication for ambulation at 2 hours after the end of the procedure\n* Patients with a life expectancy of less then 1 month.'}, 'identificationModule': {'nctId': 'NCT01911403', 'acronym': 'AGIR', 'briefTitle': 'AGIR Study: Angio-Seal in Interventional Radiology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology', 'orgStudyIdInfo': {'id': 'CV08025POVC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angio-Seal', 'description': 'Closure procedure by Angio-Seal', 'interventionNames': ['Device: Angio-Seal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual compression', 'description': 'Closure procedure by manual compression', 'interventionNames': ['Procedure: Manual compression']}], 'interventions': [{'name': 'Manual compression', 'type': 'PROCEDURE', 'description': 'Closure procedure by Manual compression', 'armGroupLabels': ['Manual compression']}, {'name': 'Angio-Seal', 'type': 'DEVICE', 'description': 'Closure procedure by angio-Seal', 'armGroupLabels': ['Angio-Seal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4202-451', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital de São João, E.P.E.', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Dr. Alberto Mingo, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de La Princesa, Madrid'}, {'name': 'Dr. Paolo Morgado, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de São João, E.P.E.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}