Clinical trial NCT01415804: Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
Official title: A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aortic Dissection
Keywords: Dissection
Aorta
Surgery
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis versus medical management in patients with dissection of the thoracic aorta.

Detailed description: Patients \> 18 years with type B aortic dissection were randomized to either thoracic aortic endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only stable patients without spontaneous false lumen thrombosis 14 days after index dissection were considered eligible for study inclusion. Long-term outcome measures included all-cause mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of disease, conversion and additional interventions); the analysis is based on 140 randomized cases followed for at least 5 years.

Eligibility criteria: Inclusion Criteria:

* No contraindication the general anesthesia and ventilation
* Type B aortic dissection that occurred 2-52 weeks prior to randomization
* Diameter of the targeted aortic segment \< 6 cm
* Subject or legal guardian understand the nature of teh study and agrees to its provisions on a written informed consent form
* Availability for appropriate follow-up visits during the F/U period of 5 years
* Capability to follow all study requirements

Exclusion Criteria:

* Pregnancy
* Thrombocytopenia
* Ongoing anticoagulation therapy
* Renal failure and/or creatinine \> 2,4 mg%
* Complete thrombosis of false lumen
* Cancer likely to cause death within 1 year
* Enrollment in another clinical study
* Unwillingness to cooperate with study procedures or F/U visits

Primary outcomes:
measure: All cause mortality
timeFrame: 5 years post randomization
Secondary outcomes:
measure: Aorta-specific mortality
timeFrame: 5 years post randomization
measure: Progression of disease
timeFrame: 5 years
measure: Aortic remodeling
timeFrame: 5 years
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University Hospital Rostock; Heart Center
state: MV
Study officials:
affiliation: University of Rostock
name: Christoph A Nienaber, MD
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.
citation: Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.