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

JOTEC

Status: Completed

Conditions: Type B Aortic Dissection

Study type: Observational

Funder types: Industry

Identifiers

NCT01407159

ASSIST

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

40 participants in 2 patient groups

Thoracic Stentgraft plus E-XL

Description:

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

Description:

historical control group fulfilling the following criteria: * Age +/- 3 years * Sex matched * Same follow-up period