Clinical trial NCT01407159: A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
Official title: ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type B Aortic Dissection
Keywords: type b dissection
thoracic stentgraft
aortic stent
clinical and technical success
safety and feasibility of E-XL aortic stent
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2011-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: February 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: German Heart Center
city: Essen
country: Germany
facility: University Hospital
city: Freiburg
country: Germany
facility: University Hospital
city: Hanover
country: Germany
facility: Hannover Medical School
city: Jena
country: Germany
facility: University Hospital
city: Muenster
country: Germany
facility: St. Franziskus Hospital
city: Munich
country: Germany
facility: University Hospital Munich Grosshadern
city: Rostock
country: Germany
facility: University Hospital
city: Bologna
country: Italy
facility: Department of Radiologia Toracica e Vascolare
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato Milano
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Barcelona
country: Spain
facility: Thorax Insitute, Hospital Clinic, University of Barcelona
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
References:
citation: Nienaber CA, Yuan X, Aboukoura M, Blanke P, Jakob R, Janosi RA, Lovato L, Riambau V, Trebacz J, Trimarchi S, Zipfel B, van den Berg JC; ASSIST study group. Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection. Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20.