A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Type B Aortic Dissection Clinical Trial

— ASSIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407159
• Other study ID #: ASSIST
• Status: Completed
• Phase: N/A
• First received: July 29, 2011
• Last updated: April 25, 2014
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: JOTEC GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type B Aortic Dissection

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Germany	German Heart Center	Berlin
Germany	University Hospital	Essen
Germany	University Hospital	Freiburg
Germany	Hannover Medical School	Hanover
Germany	University Hospital	Jena
Germany	St. Franziskus Hospital	Muenster
Germany	University Hospital Munich Grosshadern	Munich
Germany	University Hospital	Rostock
Italy	Department of Radiologia Toracica e Vascolare	Bologna
Italy	IRCCS Policlinico San Donato Milano	Milan
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Lublin
Spain	Thorax Insitute, Hospital Clinic, University of Barcelona	Barcelona
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No