- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01407159
A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting (ASSIST)
ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
Cohort study according to national regulatory guidelines: Non-interventional, observational cohort study. Pair-matched comparison with patients chosen from historical series.
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 stentgraft in a single procedure.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bologna, Italien, 40138
- Department of Radiologia Toracica e Vascolare
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Milan, Italien, 20097
- IRCCS Policlinico San Donato Milano
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Kraków, Polen, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Lublin, Polen, 20-081
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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Barcelona, Spanien, 08036
- Thorax Insitute, Hospital Clinic, University of Barcelona
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Valladolid, Spanien, 47005
- Hospital Clinico Universitario de Valladolid
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Augsburg, Tyskland
- Klinikum Augsburg
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Berlin, Tyskland, 13353
- German Heart Center
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Essen, Tyskland, 45147
- University Hospital
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Freiburg, Tyskland
- University Hospital
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Hanover, Tyskland, 30625
- Hannover Medical School
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Jena, Tyskland, 07747
- University Hospital
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Muenster, Tyskland, 48145
- St. Franziskus Hospital
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Munich, Tyskland
- University Hospital Munich Grosshadern
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Rostock, Tyskland
- University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
The clinical records of the patients mus support the following criteria:
- Age > 18 years
- Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation
- The endovascular treatment may be associated with a complementary surgical operation
- 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
- Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection
- Aortic kinking < 90°
- The patient must be available for the appropriate follow-up times for the duration of the study
- Informed consent from patient or authorized relative
The data of whose patients clinical records confirm one of the following conditions will not be considered in this study:
- Patients with a contraindication as indicated in the instruction for use
- Patients with chronic thrombocytopenia or ongoing anticoagulation
- Patients with renal failure and/or creatinine >2.4mg/dl immediately before the intervention
- Patients in whom the false lumen is completely thrombosed
- Patients with ongoing infection
- Patients with ongoing cancer
- Patients who are enrolled in a clinical study
- Aortic landing zone diameter over 40 mm
- Potentially emboligenic iliac and aortic atheroma lesions
- Associated pathology with life expectancy of less than 24 months
- Unstable infectious syndrome
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Thoracic Stentgraft plus E-XL
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
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Control group
historical control group fulfilling the following criteria:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: February 2014
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February 2014
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ASSIST
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