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

Sponsor

JOTEC GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01407159

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Type B Aortic Dissection

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

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. [February 2014]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Klinikum Augsburg	Augsburg	Germany
2	German Heart Center	Berlin	Germany	13353
3	University Hospital	Essen	Germany	45147
4	University Hospital	Freiburg	Germany
5	Hannover Medical School	Hanover	Germany	30625
6	University Hospital	Jena	Germany	07747
7	St. Franziskus Hospital	Muenster	Germany	48145
8	University Hospital Munich Grosshadern	Munich	Germany
9	University Hospital	Rostock	Germany
10	Department of Radiologia Toracica e Vascolare	Bologna	Italy	40138
11	IRCCS Policlinico San Donato Milano	Milan	Italy	20097
12	Krakowski Szpital Specjalistyczny im. Jana Pawła II	Kraków	Poland	31-202
13	Samodzielny Publiczny Szpital Kliniczny Nr 1	Lublin	Poland	20-081
14	Thorax Insitute, Hospital Clinic, University of Barcelona	Barcelona	Spain	08036
15	Hospital Clinico Universitario de Valladolid	Valladolid	Spain	47005