Type B Aortic DissectionASSISTNCT01407159
A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
An observational study of Type B Aortic Dissection, run by JOTEC GmbH at 15 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Aortic Dissection
- How many people
- 40 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Nov 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany9 sites
Klinikum Augsburg
Augsburg
German Heart Center
Berlin, 13353
University Hospital
Essen, 45147
University Hospital
Freiburg im Breisgau
Hannover Medical School
Hanover, 30625
University Hospital
Jena, 07747
University Hospital Munich Grosshadern
Munich
St. Franziskus Hospital
Münster, 48145
University Hospital
Rostock
Italy2 sites
Department of Radiologia Toracica e Vascolare
Bologna, 40138
IRCCS Policlinico San Donato Milano
Milan, 20097
Poland2 sites
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, 20-081
Spain2 sites
Thorax Insitute, Hospital Clinic, University of Barcelona
Barcelona, 08036
Hospital Clinico Universitario de Valladolid
Valladolid, 47005
About this study
Official title: ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: February 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407159
- Sponsor's protocol ID
- ASSIST
- Acronym
- ASSIST
- Status last verified
- Apr 2014
- First submitted
- 29 Jul 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
Publications
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.
PubMed 32205112
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting
- ClinicalTrials.gov ID
- NCT01407159
- Acronym / sponsor ID
- ASSIST / ASSIST
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with complicated type B aortic dissection involving the infra-diaphragmatic aorta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Derived from this study: PubMed 32205112Nienaber 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.
Related trials for Type B Aortic Dissection
Recruiting
IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Type B Aortic Dissection
Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Type B Aortic Dissection
Not yet recruitingObservational study
Type B Aortic Dissection Quality Control Platform
Endovascular Surgery, Medical Quality
Recruiting
WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection
Aortic Dissection Type B
Enrolling by invitationObservational study
Outcomes of Aortic Dissection Repair
Type A Aortic Dissection, Ascending Aortic Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type B Aortic Dissection, run by JOTEC GmbH at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Italy, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.