A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting (ASSIST)
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Purpose
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 |
|---|
|
Type B Aortic Dissection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting |
- 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. [ Time Frame: February 2014 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
Contacts and Locations| Germany | |
| Klinikum Augsburg | Recruiting |
| Augsburg, Germany | |
| Contact: Rudolf Jakob, Dr. +49821400 ext 01 | |
| Principal Investigator: Rudolf Jakob, Dr. | |
| German Heart Center | Recruiting |
| Berlin, Germany, 13353 | |
| Contact: Burkhart Zipfel, Dr. +49304593 ext 0 | |
| Principal Investigator: Burkhart Zipfel, Dr. | |
| University Hospital | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Alexander Jànosi, Dr. +49201723 ext 0 | |
| Principal Investigator: Alexander Jànosi, Dr. | |
| University Hospital | Recruiting |
| Freiburg, Germany | |
| Contact: Philipp Blanke, Dr. +49761270 ext 0 | |
| Principal Investigator: Philpp Blanke, Dr. | |
| Hannover Medical School | Completed |
| Hanover, Germany, 30625 | |
| University Hospital | Recruiting |
| Jena, Germany, 07747 | |
| Contact: Juergen Zanow, Dr. +493461932 ext 2601 | |
| Principal Investigator: Juergen Zanow, Dr. | |
| St. Franziskus Hospital | Completed |
| Muenster, Germany, 48145 | |
| University Hospital Munich Grosshadern | Completed |
| Munich, Germany | |
| University Hospital | Recruiting |
| Rostock, Germany | |
| Contact: Christoph Nienaber, Prof. +49381494 ext 7700 | |
| Principal Investigator: Christoph Nienaber, Prof. | |
| Italy | |
| Department of Radiologia Toracica e Vascolare | Recruiting |
| Bologna, Italy, 40138 | |
| Contact: Luigi Lovato, Dr. +3951 ext 6361259 | |
| Principal Investigator: Luigi Lovato, Dr. | |
| IRCCS Policlinico San Donato Milano | Recruiting |
| Milan, Italy, 20097 | |
| Contact: Santi Trimarchi, Dr. +3902 ext 527741 | |
| Principal Investigator: Santi Trimarchi, Dr. | |
| Poland | |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Recruiting |
| Kraków, Poland, 31-202 | |
| Contact: Jarosław Trębacz, Dr. +48126142000 | |
| Principal Investigator: Jarosław Trębacz, Dr. | |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 | Recruiting |
| Lublin, Poland, 20-081 | |
| Contact: Jan Jakub Kęsik, Dr. +48815325707 | |
| Principal Investigator: Jan Jakub Kęsik, Dr. | |
| Spain | |
| Thorax Insitute, Hospital Clinic, University of Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Vincent Riambau, MD, PhD +34932275515 | |
| Principal Investigator: Vincent Riambau, MD, PhD | |
| Hospital Clinico Universitario de Valladolid | Completed |
| Valladolid, Spain, 47005 | |
More Information
No publications provided
| Responsible Party: | Jotec GMBH |
| ClinicalTrials.gov Identifier: | NCT01407159 History of Changes |
| Other Study ID Numbers: | ASSIST |
| Study First Received: | July 29, 2011 |
| Last Updated: | March 5, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Jotec GMBH:
|
type b dissection thoracic stentgraft aortic stent clinical and technical success safety and feasibility of E-XL aortic stent |
ClinicalTrials.gov processed this record on May 21, 2013