A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Type B Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Control group

historical control group fulfilling the following criteria:

* Age +/- 3 years
* Sex matched
* Same follow-up period

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No