Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT03044002
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2017-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIOTRONIK 4French for AMBulatory Peripheral Intervention
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 821}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-03', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)', 'timeFrame': 'up to 30 days post procedure', 'description': 'Access site complications are defined as a composite of:\n\n* Groin hematoma (larger than 5 cm in diameter, visible by sonography, and hemoglobin decrease \\<3 g/dL)\n* Pseudoaneurysm\n* Groin as well as retroperitoneal bleeding (defined as requiring acute intervention for haemostasis, need for blood transfusions, or haemoglobin decrease \\>3 g/dL)\n* AV fistula (visible by shunting in colour coded sonography between the common femoral artery and vein)\n* Arterial dissections at access site (visible with fluoroscopy or sonography as a membrane causing stenosis in the vessel lumen)\n* Thrombosis\n* VCD related ASCs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease', 'Access Site Complication', 'Outpatient Treatment']}, 'descriptionModule': {'briefSummary': 'BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory setting: BIO4AMB', 'detailedDescription': 'Controlled, multicenter, non-inferiority trial to compare the rate of access site complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years or minimum age as required by local regulations\n* Ability to walk\n* Subject must be willing to sign patient Informed Consent (PIC)\n* Patient with infrainguinal arteries lesion(s) suitable to be treated during an ambulatory endovascular intervention\n\nExclusion Criteria:\n\n* No possibility of an ambulatory management\n* Physical fitness classified as ASA ≥ 4 (American Society of Anaesthesiologists)\n* Coagulation disorders\n* Acute ischemia\n* Less than 1month live expectancy\n* Pregnant or breast feeding females or females who intend to become pregnant during the time of the study (pregnancy test required for all women with child bearing potential)\n* Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures\n* Patient contraindicated for antiplatelet therapy, anticoagulants and antithrombotics\n* Other access than common femoral\n* Home alone the first night'}, 'identificationModule': {'nctId': 'NCT03044002', 'acronym': 'BIO4AMB', 'briefTitle': 'BIOTRONIK 4French for AMBulatory Peripheral Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik AG'}, 'officialTitle': 'BIOTRONIK 4French for AMBulatory Peripheral Intervention. A Multicenter, Controlled Trial Comparing 4French Versus 6French Femoral Access for Endovascular Treatment of Lower-extremity Peripheral Artery Disease in an Ambulatory Setting: BIO4AMB', 'orgStudyIdInfo': {'id': 'C1602'}}, 'armsInterventionsModule': {'armGroups': [{'label': '4French Intervention', 'description': 'Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment', 'interventionNames': ['Device: Biotronik 4 French Portfolio']}, {'label': '6French Intervention', 'description': 'Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment', 'interventionNames': ['Device: 6 French Portfolio']}], 'interventions': [{'name': 'Biotronik 4 French Portfolio', 'type': 'DEVICE', 'description': 'Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease', 'armGroupLabels': ['4French Intervention']}, {'name': '6 French Portfolio', 'type': 'DEVICE', 'description': 'Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease', 'armGroupLabels': ['6French Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'A.Z.Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Trélazé', 'country': 'France', 'facility': 'Clinique Saint Joseph', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Osepedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'PD Dott. med. Jos van den Berg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Regionale di Lugano - Sezione Civico'}, {'name': 'a.o. Univ. Prof. Dr. Marianne Brodmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}