Clinical trial NCT00525356: INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Official title: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Diseases
Keywords: Aorta
Dissection
Thoracic
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare treatment with an endograft prothesis versus antihypertensive treatment in patients with a dissection of the thoracic aorta.

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.

Eligibility criteria: 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Medtronic Bakken Research Center
Study officials:
affiliation: Division of Cardiology and Internal Medicine Department, Rostock University, Germany.
name: C A Nienaber, MD, FESC, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.