Investigation of Stent-grafts in Aortic Dissection (INSTEAD)

Aortic Dissection Clinical Trial

— INSTEAD  

Official title:

A Randomized Comparison of Strategies for Type B Aortic Dissection - the INvestigation of STEnt-grafts in Aortic Dissection (INSTEAD) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415804
• Other study ID #: NCT00525356
• Secondary ID: INSTEAD 5 years
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 11, 2011
• Last updated: August 11, 2011
• Start date: February 2002
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Device:
• endoprosthesis
Thoracic aortic stentgraft

Locations

Country	Name	City	State
Germany	University Hospital Rostock; Heart Center	Rostock	MV

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

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 STEn — 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		5 years post randomization	Yes
Secondary	Aorta-specific mortality		5 years post randomization	Yes
Secondary	Progression of disease		5 years	No
Secondary	Aortic remodeling		5 years	No