INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Aortic Diseases Clinical Trial

— INSTEAD  

Official title:

INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525356
• Other study ID #: INSTEAD trial
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2007
• Last updated: October 28, 2015
• Start date: February 2002
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Germany: Ethics CommissionItaly: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Diseases

Intervention

Device:
• Medtronic Talent Stent-Graft-System

Locations

Country	Name	City	State
Netherlands	Medtronic Bakken Research Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality		1 year
Secondary	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.		5 years