A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting (ASSIST)
Tracking Information | |
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First Received Date ICMJE | July 29, 2011 |
Last Updated Date | January 20, 2012 |
Start Date ICMJE | November 2011 |
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT01407159 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting |
Official Title ICMJE | ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting |
Brief Summary | 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. |
Detailed Description | |
Study Type ICMJE | Observational |
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
Biospecimen | |
Sampling Method | Probability Sample |
Study Population | tmale and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta |
Condition ICMJE | Type B Aortic Dissection |
Intervention ICMJE | |
Study Group/Cohort (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Recruiting |
Estimated Enrollment ICMJE | 30 |
Estimated Completion Date | November 2013 |
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | The clinical records of the patients mus support the following criteria:
The data of whose patients clinical records confirm one of the following conditions will not be considered in this study:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Germany |
Administrative Information | |
NCT Number ICMJE | NCT01407159 |
Other Study ID Numbers ICMJE | ASSIST |
Has Data Monitoring Committee | |
Responsible Party | Jotec GMBH |
Study Sponsor ICMJE | Jotec GMBH |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Jotec GMBH |
Verification Date | January 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |