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
  Purpose

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.


Condition
Type B Aortic Dissection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Further study details as provided by Jotec GMBH:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407159

Locations
Germany
Klinikum Augsburg Recruiting
Augsburg, Germany
Contact: Rudolf Jakob, Dr.     +49821400 ext 01        
Principal Investigator: Rudolf Jakob, Dr.            
German Heart Center Recruiting
Berlin, Germany, 13353
Contact: Burkhart Zipfel, Dr.     +49304593 ext 0        
Principal Investigator: Burkhart Zipfel, Dr.            
University Hospital Recruiting
Essen, Germany, 45147
Contact: Alexander Jànosi, Dr.     +49201723 ext 0        
Principal Investigator: Alexander Jànosi, Dr.            
University Hospital Recruiting
Freiburg, Germany
Contact: Philipp Blanke, Dr.     +49761270 ext 0        
Principal Investigator: Philpp Blanke, Dr.            
Hannover Medical School Completed
Hanover, Germany, 30625
University Hospital Recruiting
Jena, Germany, 07747
Contact: Juergen Zanow, Dr.     +493461932 ext 2601        
Principal Investigator: Juergen Zanow, Dr.            
St. Franziskus Hospital Completed
Muenster, Germany, 48145
University Hospital Munich Grosshadern Completed
Munich, Germany
University Hospital Recruiting
Rostock, Germany
Contact: Christoph Nienaber, Prof.     +49381494 ext 7700        
Principal Investigator: Christoph Nienaber, Prof.            
Italy
Department of Radiologia Toracica e Vascolare Recruiting
Bologna, Italy, 40138
Contact: Luigi Lovato, Dr.     +3951 ext 6361259        
Principal Investigator: Luigi Lovato, Dr.            
IRCCS Policlinico San Donato Milano Recruiting
Milan, Italy, 20097
Contact: Santi Trimarchi, Dr.     +3902 ext 527741        
Principal Investigator: Santi Trimarchi, Dr.            
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II Recruiting
Kraków, Poland, 31-202
Contact: Jarosław Trębacz, Dr.     +48126142000        
Principal Investigator: Jarosław Trębacz, Dr.            
Samodzielny Publiczny Szpital Kliniczny Nr 1 Recruiting
Lublin, Poland, 20-081
Contact: Jan Jakub Kęsik, Dr.     +48815325707        
Principal Investigator: Jan Jakub Kęsik, Dr.            
Spain
Thorax Insitute, Hospital Clinic, University of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Vincent Riambau, MD, PhD     +34932275515        
Principal Investigator: Vincent Riambau, MD, PhD            
Hospital Clinico Universitario de Valladolid Completed
Valladolid, Spain, 47005
Sponsors and Collaborators
Jotec GMBH
  More Information

No publications provided

Responsible Party: Jotec GMBH
ClinicalTrials.gov Identifier: NCT01407159     History of Changes
Other Study ID Numbers: ASSIST
Study First Received: July 29, 2011
Last Updated: March 5, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Jotec GMBH:
type b dissection
thoracic stentgraft
aortic stent
clinical and technical success
safety and feasibility of E-XL aortic stent

ClinicalTrials.gov processed this record on May 22, 2013