Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-27 @ 8:25 AM
Study NCT ID:
NCT01407159
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2011-07-29', 'studyFirstSubmitQcDate': '2011-08-01', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic thoracic stent-graft in a single procedure.', 'timeFrame': 'February 2014'}]}, 'conditionsModule': {'keywords': ['type b dissection', 'thoracic stentgraft', 'aortic stent', 'clinical and technical success', 'safety and feasibility of E-XL aortic stent'], 'conditions': ['Type B Aortic Dissection']}, 'referencesModule': {'references': [{'pmid': '32205112', 'type': 'DERIVED', 'citation': 'Nienaber CA, Yuan X, Aboukoura M, Blanke P, Jakob R, Janosi RA, Lovato L, Riambau V, Trebacz J, Trimarchi S, Zipfel B, van den Berg JC; ASSIST study group. Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection. Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'Cohort study according to national regulatory guidelines: Non-interventional, observational cohort study. Pair-matched comparison with patients chosen from historical series.\n\nTo evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic stentgraft in a single procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta', 'healthyVolunteers': False, 'eligibilityCriteria': 'The clinical records of the patients mus support the following criteria:\n\n* Age \\> 18 years\n* Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation\n* The endovascular treatment may be associated with a complementary surgical operation\n* The total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation\n* Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection\n* Aortic kinking \\< 90°\n* The patient must be available for the appropriate follow-up times for the duration of the study\n* Informed consent from patient or authorized relative\n\nThe data of whose patients clinical records confirm one of the following conditions will not be considered in this study:\n\n* Patients with a contraindication as indicated in the instruction for use\n* Patients with chronic thrombocytopenia or ongoing anticoagulation\n* Patients with renal failure and/or creatinine \\>2.4mg/dl immediately before the intervention\n* Patients in whom the false lumen is completely thrombosed\n* Patients with ongoing infection\n* Patients with ongoing cancer\n* Patients who are enrolled in a clinical study\n* Aortic landing zone diameter over 40 mm\n* Potentially emboligenic iliac and aortic atheroma lesions\n* Associated pathology with life expectancy of less than 24 months\n* Unstable infectious syndrome'}, 'identificationModule': {'nctId': 'NCT01407159', 'acronym': 'ASSIST', 'briefTitle': 'A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting', 'organization': {'class': 'INDUSTRY', 'fullName': 'JOTEC GmbH'}, 'officialTitle': 'ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting', 'orgStudyIdInfo': {'id': 'ASSIST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thoracic Stentgraft plus E-XL', 'description': 'male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta treated with any thoracic stentgraft extended by the E-XL aortic stent'}, {'label': 'Control group', 'description': 'historical control group fulfilling the following criteria:\n\n* Age +/- 3 years\n* Sex matched\n* Same follow-up period'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'University Hospital Munich Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskus Hospital', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Department of Radiologia Toracica e Vascolare', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20097', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Krakowski Szpital Specjalistyczny im. Jana Pawła II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Thorax Insitute, Hospital Clinic, University of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '47005', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JOTEC GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}