Status:
COMPLETED
A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
Lead Sponsor:
JOTEC GmbH
Conditions:
Type B Aortic Dissection
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01407159
Start Date
November 1 2011
End Date
January 1 2014
Last Update
April 28 2014
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinikum Augsburg
Augsburg, Germany
2
German Heart Center
Berlin, Germany, 13353
3
University Hospital
Essen, Germany, 45147
4
University Hospital
Freiburg im Breisgau, Germany