- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bologna, Italia, 40138
- Department of Radiologia Toracica e Vascolare
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Milan, Italia, 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, Spania, 08036
- Thorax Insitute, Hospital Clinic, University of Barcelona
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Valladolid, Spania, 47005
- Hospital Clínico 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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ASSIST
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