A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

NCT01407159 | Completed

• 1 other identifier: ASSIST
• Study Type: observational
• Target: 40
• Locations: 4 countries
• Sites: 15

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.

Conditions

Type B Aortic Dissection

Keywords

type b dissection; thoracic stentgraft; aortic stent; clinical and technical success; safety and feasibility of E-XL aortic stent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (15)

Klinikum Augsburg

Augsburg, Germany

Location

German Heart Center

Berlin, 13353, Germany

Location

University Hospital

Essen, 45147, Germany

Location

University Hospital

Freiburg im Breisgau, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

University Hospital

Jena, 07747, Germany

Location

University Hospital Munich Grosshadern

Munich, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

University Hospital

Rostock, Germany

Location

Department of Radiologia Toracica e Vascolare

Bologna, 40138, Italy

Location

IRCCS Policlinico San Donato Milano

Milan, 20097, Italy

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, 31-202, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, 20-081, Poland

Location

Thorax Insitute, Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Related Publications (1)

• Nienaber CA, Yuan X, Aboukoura M, Blanke P, Jakob R, Janosi RA, Lovato L, Riambau V, Trebacz J, Trimarchi S, Zipfel B, van den Berg JC; ASSIST study group. Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection. Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20.

  PMID: 32205112 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

IT (2); ES (2); PL (2); DE (9)