- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525356
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection (INSTEAD)
INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients older than 18 years with type B aortic dissection as diagnosed by computed tomography or magnetic resonance angiography are randomized to either a thoracic aortic endoprosthesis and antihypertensive treatment, called "stent grafting," or a tailored antihypertensive treatment, called "medical treatment."
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Maastricht, Netherlands, 6229 GW
- Medtronic Bakken Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No contraindication for an anesthetic procedure with intubation
- 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:
- Pregnant woman
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Anti-hypertensive medical treatment
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all-cause mortality
Time Frame: 1 year
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
thrombosis of the false lumen, cardiovascular morbidity, degree of aortic expansion, length of intensive care and hospital stay, and quantitative assessment of single or combination antihypertensive drug therapy.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: C A Nienaber, MD, FESC, FACC, Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INSTEAD trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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