Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-10 @ 12:39 PM
Study NCT ID:
NCT03192033
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A duplex scan guided retrograde femoral puncture is performed followed by the use of a closure arterial device to ensure hemostasis. Patients are randomly assigned to be closed by Proglide® (Abbott) versus Femoseal® (Terumo)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-16', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success defined as hemostasis at the puncture site without major complications.', 'timeFrame': 'Hour 5'}], 'secondaryOutcomes': [{'measure': 'Occurrence of major cardio-vascular events', 'timeFrame': 'Month 1'}, {'measure': 'Occurrence of major punctured femoral artery events during the perioperative period', 'timeFrame': 'Hour 5'}, {'measure': 'Occurrence of minor punctured femoral artery events during the perioperative period', 'timeFrame': 'Hour 5'}, {'measure': 'Walking ability', 'timeFrame': 'Hour 5', 'description': 'Time before restart of the ambulation measured in minutes from when the sheath of the introducer of the arterial closure system is removed and the moment when the patient is able to walk 100 meters without the recurrence of bleeding.'}, {'measure': 'Quality of life evaluation (EQ-5D)', 'timeFrame': 'Month 1'}, {'measure': 'Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)', 'timeFrame': 'Month 1', 'description': 'The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '34386892', 'type': 'DERIVED', 'citation': "Goueffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1883-1892. doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13."}]}, 'descriptionModule': {'briefSummary': 'Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.\n\nHowever, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.\n\nThe investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years,\n* Patient with peripheral arterial disease\n* Endovascular examination or treatment compatible with a 5F to 7F sheath\n* Walking ability\n* Patient affiliated with a social security scheme\n* Patient's signed informed consent form\n\nExclusion Criteria:\n\n* Under-age patient\n* Patient of age, but under legal guardianship or care\n* Contraindication to endovascular treatment\n* Use of a 8F or greater sheath\n* Morbidity contraindicating same-day walking\n* History of ipsilateral open common femoral artery surgery\n* Stent at the puncture site\n* Radial or brachial puncture\n* Antegrade femoral puncture\n* Acute ischemia\n* Life expectancy of less than one month\n* Patient refusal to take part in the study\n* Participation in another therapeutic trial\n* Pregnant woman\n* Allergy to clopidogrel or aspirin"}, 'identificationModule': {'nctId': 'NCT03192033', 'acronym': 'STEP', 'briefTitle': 'STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures', 'orgStudyIdInfo': {'id': 'RC16_0466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arterial closure device used is Proglide® (Abbott)', 'interventionNames': ['Other: Arterial closure to ensure hemostasis at femoral artery puncture points', 'Device: Proglide® (Abbott)']}, {'type': 'OTHER', 'label': 'Arterial closure device used is Femoseal® (Terumo)', 'interventionNames': ['Device: Femoseal® (Terumo)', 'Other: Arterial closure to ensure hemostasis at femoral artery puncture points']}], 'interventions': [{'name': 'Arterial closure to ensure hemostasis at femoral artery puncture points', 'type': 'OTHER', 'description': 'Arterial closure devices used: Proglide® (Abbott)', 'armGroupLabels': ['Arterial closure device used is Proglide® (Abbott)']}, {'name': 'Proglide® (Abbott)', 'type': 'DEVICE', 'description': 'Arterial closure device used: Proglide® (Abbott)', 'armGroupLabels': ['Arterial closure device used is Proglide® (Abbott)']}, {'name': 'Femoseal® (Terumo)', 'type': 'DEVICE', 'description': 'Arterial closure device used: Femoseal® (Terumo)', 'armGroupLabels': ['Arterial closure device used is Femoseal® (Terumo)']}, {'name': 'Arterial closure to ensure hemostasis at femoral artery puncture points', 'type': 'OTHER', 'description': 'Arterial closure device used: Femoseal® (Terumo)', 'armGroupLabels': ['Arterial closure device used is Femoseal® (Terumo)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Cholet', 'country': 'France', 'facility': 'CH de Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD La Roche-sur-Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Philippe CHAILLOU, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}