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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Jotec GMBH.
Recruitment status was  Recruiting
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 April 22, 2014