INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
NCT ID: NCT00525356
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2002-02-28
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
NCT01415804
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
NCT00816062
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
NCT03752996
The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection（BROAD）
NCT05659641
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
NCT00805948
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Only patients in a clinically stable condition and without spontaneous thrombosis of the false lumen after 14 days of the index dissection are considered eligible for study inclusion.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (\>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study design calls for 136 patients to be randomized and monitored for 24 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Anti-hypertensive medical treatment
Medtronic Talent Stent-Graft-System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medtronic Talent Stent-Graft-System
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Type B aortic dissection that occurred 2-52 weeks before randomization
* Diameter of the targeted aortic segment ≤6 cm
* Aortic kinking \<75°
* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
* Availability for the appropriate follow-up visits during the follow-up period
* Capability to follow all study requirements
Exclusion Criteria
* Thrombocytopenia or ongoing anticoagulation therapy
* Renal failure and/or creatinine \>2.4 mg%
* Complete thrombosis of the false lumen
* Ongoing infection
* Cancer is likely to cause death within 1 year
* Enrolment in another clinical study
* Unwillingness to cooperate with study procedures or follow-up visits
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
C A Nienaber, MD, FESC, FACC
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medtronic Bakken Research Center
Maastricht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Nienaber CA, Zannetti S, Barbieri B, Kische S, Schareck W, Rehders TC; INSTEAD study collaborators. INvestigation of STEnt grafts in patients with type B Aortic Dissection: design of the INSTEAD trial--a prospective, multicenter, European randomized trial. Am Heart J. 2005 Apr;149(4):592-9. doi: 10.1016/j.ahj.2004.05.060.
Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INSTEAD trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.