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

July 29, 2011
March 5, 2013
November 2011
February 2014   (final data collection date for primary outcome 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. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01407159 on ClinicalTrials.gov Archive Site
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A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

Type B Aortic Dissection
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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Germany,   Italy,   Poland,   Spain
 
NCT01407159
ASSIST
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Jotec GMBH
Jotec GMBH
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Jotec GMBH
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP