A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting (ASSIST)

This study is currently recruiting participants.

Verified January 2012 by Jotec GMBH

Sponsor:

Information provided by (Responsible Party):

Jotec GMBH

ClinicalTrials.gov Identifier:

NCT01407159

First received: July 29, 2011

Last updated: March 5, 2013

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 29, 2011
Last Updated Date	March 5, 2013
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 15, 2013)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01407159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta
Condition ^ICMJE	Type B Aortic Dissection
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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 Control group historical control group fulfilling the following criteria: Age +/- 3 years Sex matched Same follow-up period
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Completion Date	Not Provided
Estimated Primary Completion Date	February 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany, Italy, Poland, Spain

Administrative Information
NCT Number ^ICMJE	NCT01407159
Other Study ID Numbers ^ICMJE	ASSIST
Has Data Monitoring Committee	Not Provided
Responsible Party	Jotec GMBH
Study Sponsor ^ICMJE	Jotec GMBH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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