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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JOTEC GmbH
ClinicalTrials.gov Identifier:
NCT01407159
First received: July 29, 2011
Last updated: April 25, 2014
Last verified: April 2014
  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 ]

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Klinikum Augsburg
Augsburg, Germany
German Heart Center
Berlin, Germany, 13353
University Hospital
Essen, Germany, 45147
University Hospital
Freiburg, Germany
Hannover Medical School
Hanover, Germany, 30625
University Hospital
Jena, Germany, 07747
St. Franziskus Hospital
Muenster, Germany, 48145
University Hospital Munich Grosshadern
Munich, Germany
University Hospital
Rostock, Germany
Italy
Department of Radiologia Toracica e Vascolare
Bologna, Italy, 40138
IRCCS Policlinico San Donato Milano
Milan, Italy, 20097
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Kraków, Poland, 31-202
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland, 20-081
Spain
Thorax Insitute, Hospital Clinic, University of Barcelona
Barcelona, Spain, 08036
Hospital Clinico Universitario de Valladolid
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: April 25, 2014
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 October 23, 2014