- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Augsburg, Germany
- Klinikum Augsburg
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Berlin, Germany, 13353
- German Heart Center
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Essen, Germany, 45147
- University Hospital
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Freiburg, Germany
- University Hospital
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Hanover, Germany, 30625
- Hannover Medical School
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Jena, Germany, 07747
- University Hospital
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Muenster, Germany, 48145
- St. Franziskus Hospital
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Munich, Germany
- University Hospital Munich Grosshadern
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Rostock, Germany
- University Hospital
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Bologna, Italy, 40138
- Department of Radiologia Toracica e Vascolare
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Milan, Italy, 20097
- IRCCS Policlinico San Donato Milano
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Kraków, Poland, 31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Lublin, Poland, 20-081
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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Barcelona, Spain, 08036
- Thorax Insitute, Hospital Clinic, University of Barcelona
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Valladolid, Spain, 47005
- Hospital Clinico Universitario de Valladolid
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: February 2014
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February 2014
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASSIST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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